Search
Find a Provider
Agent Registration
Facebook Linkedin Instagram

Drug Withdrawals and Recalls

A drug recall or withdrawal is when a drug is taken off the shelves because something may be wrong with it. This helps keep people safe from a product that could cause harm. When possible, Upper Peninsula Health Plan (UPHP) will tell members and their providers about drug withdrawals and recalls that may affect them.

UPHP posts the following types of recalls on this website:

Class I Recalls: When there is a good chance that using a product, or being exposed to it, will cause serious negative health problems or death.

Class II Recall: When using or being exposed to a product may cause short-term or reversible negative health problems, or the chance of serious negative health problems is very low.

Lot-specific Recall: When only certain lots of a product are recalled for safety reasons. Other lots are still safe to use. UPHP cannot tell which lot(s) a member may have been given.

Safety-Related Market Withdrawal: When the FDA decides a drug product is unsafe and all of it must be removed from the market.

You can see our Pharmaceutical Safety policy at UPHP Pharmacy Policies

You can also find more recall information on the Food and Drug Administration (FDA) website at Recalls, Market Withdrawals, & Safety Alerts | FDA

Recall DateClassification DateFDA Notification DateClassificationRecalled DrugProduct InformationRecall reasonLink to FDA press release; if available
7/22/20267/24/20268/5/2026Class IIDorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.Lot # DLHU0031, Exp Date: 06/30/2027.Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
7/2/2026N/A8/5/2026Not Yet ClassifiedMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.Lot #: 3241653Presence of precipitate
7/16/2026N/A8/5/2026Not Yet ClassifiedDabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.Lot: 25141583, Exp. April 30, 2027.Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities
7/16/2026N/A8/5/2026Not Yet ClassifiedDabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.Lot: 25141585, Exp. April 30, 2027.Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities
7/16/2026N/A8/5/2026Not Yet ClassifiedDabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.Lot: 25141586, Exp. April 30, 2027.Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities
7/8/20267/20/20267/29/2026Class IIAmlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30Lot 25121311, expiry 3/31/2028Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61Lot#: N02212, Exp. Date 07/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61Lot #: N02200, Exp. Date 10/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61Lot# N02172, exp 07/2026; N02296, N02288, Exp. Date 12/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61Lot #: N02310, Exp. Date 01/2027Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61Lot #: N02203, Exp. Date 09/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61Lot #: N02266, Exp. Date 11/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61Lot #: N02167, Exp. Date 07/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61 Bag lot #: N02212A, N02212B, Exp. Date 07/2026; Blister lot #: N02212, Exp. Date 07/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61 Bag lot #: N02200A, N02200B, Exp. Date 10/2026; Blister lot #: N02200, Exp. Date 10/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61 Bag lot #: N02172A, N02172B, Exp. Date 07/2026; N02288A, N02288B, Exp. Date 12/2026; Blister lot #: N02172, Exp. Date 07/2026; N02288, Exp. Date 12/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61 Bag lot #: N02266A, N02266B, Exp. Date 11/2026; Blister lot #: N02266, Exp. Date 11/2026Subpotent Drug
7/13/20267/17/20267/29/2026Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61 Bag lot #: N02167A, Exp. Date 07/2026; Blister lot # N02167, Exp. Date 07/2026Subpotent Drug
7/13/20267/23/20267/29/2026Class IIRising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.Presence of Precipitate: medication was crystallizing and particles floating in the bottle
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V, 6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02.Lack of Assurance of Sterility
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.Lack of Assurance of Sterility
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2Lot #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02.Lack of Assurance of Sterility
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1Lot #: 3H1V, 3H1VA, Exp. Date 2025/07; 3J1V, 3J2V, Exp. Date 2025/09; 3K1V, Exp. Date 2025/10; 4F1V, Exp. Date 2027/05; 4F1VA, Exp. Date 2027/05; 4H1V, Exp. Date 2027/07; 4I1V, Exp. Date 2027/08; 4K1V, 4K2V,Exp. Date 2027/10; 5A1V, 5A2V, Exp. Date 2027/12; 5D1V, Exp. Date 2028/03; 5E1V, Exp. Date2028/04; 5J1V, 5J2V, Exp. Date 2028/09; 6B1V, Exp. Date 2029/01; 6C1V, 6C1VA, 6C1VB, Exp. Date 2029/02.Lack of Assurance of Sterility
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09Lack of Assurance of Sterility
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11.Lack of Assurance of Sterility
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08Lack of Assurance of Sterility
7/14/20267/23/20267/29/2026Class IIRohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01.Lack of Assurance of Sterility
7/16/20267/23/20267/29/2026Class IIGlycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07Lot #: 6134349, 6134620 Exp. Date 11/2026Presence of Particulate Matter: Hair was found in product
7/16/20267/23/20267/29/2026Class IILidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01Lot #: 6133801, Exp. Date 01/2028Presence of Particulate Matter: Hair was found in products
7/16/20267/23/20267/29/2026Class IINaropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05Lot #: 6133436, Exp. Date 10/2028Presence of Particulate Matter: Hair was found in products
7/16/20267/23/20267/29/2026Class IIXylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01Lot #: 6130235, Exp. Date 02/2027Presence of Particulate Matter: Hair was found in products
7/16/20267/23/20267/29/2026Class IIXylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03Lot #: 6133986, Exp. Date 02/2029Presence of Particulate Matter: Hair was found in products
6/26/2026N/A7/29/2026Not Yet ClassifiedDivalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.Lot# 704C003, Exp. 12/31/2028Presence of Foreign Tablets/Capsules
6/24/2026N/A7/29/2026Not Yet ClassifiedCetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCTCross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine | FDA
6/30/2026N/A7/29/2026Not Yet ClassifiedDabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.Lot: 25141707, Exp 4/30/2027.Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
6/30/2026N/A7/29/2026Not Yet ClassifiedDabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.Lot: 25141584, Exp 4/30/2027.Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
7/6/2026N/A7/29/2026Not Yet ClassifiedTrokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.Lot # 2075801, Exp Date: 31-Oct-2029.Failed Dissolution Specifications
7/14/2026N/A7/29/2026Not Yet ClassifiedGlycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).Lot # 506033, Exp Date: 11/30/2026.Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
6/25/20267/14/20267/22/2026Class IICVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IIClinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.Lot: a) 1504241, exp 2027-03; b) 1504291, 1504301, exp 2027-03.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IIQC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.Lot: a) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IITopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IIAUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IIFAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.Lot: 1505124, 1505311, 1505332, expires: 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IIGOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IILEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IIFoster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IImeijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.Lot:1505344, exp 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/25/20267/14/20267/22/2026Class IICAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.Lot:1505141, exp 2027-04.SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
6/23/20267/13/20267/22/2026Class IINystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35Lot #: 205060, Exp 09/30/2027Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
7/6/20267/14/20267/22/2026Class IICLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.Lot #: 1239521, 1237454, Exp. Date 10/2027Lack of Assurance of Sterility
7/9/20267/15/20267/22/2026Class IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, Exp. 5/31/2028; 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, Exp. 6/30/2028; 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, Exp. 7/31/2028; 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189, Exp. 8/31/2028; 5254509, 5274692, 5276968, 5279226, 5280240, Exp. 9/30/2028; 5305661, 5307185, 5309623, 5310701, Exp. 10/31/2028; 5346128, 5350797, Exp. 12/31/2028; 6031034, 6031234, 6037918, Exp. 1/31/2029; 6051588, 6054213, 6062168, 6063361, Exp. 2/28/2029; 6069891, Exp. 3/31/2029; 6111107, Exp. 4/30/2029.Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
6/7/20267/7/20267/15/2026Class IIMethohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31Lot #: 7000612A, Exp. Date 1/2028Failed Impurities/Degradation Specifications
5/19/20267/15/20267/15/2026Class IIClomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India. Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029.cGMP deviations
6/11/20267/7/20267/15/2026Class IIMedline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04Lots 0001882643, 0001887165, 0001888441, 0001900835, 0001931329 & 0001951664 May 2026 Lots 0001882644, 0001899186, 0001903516, 0001905970, 0001911902, 0001917707 & 0001920638 June 2026 Lot 0001927080 Oct 2026 Lots 0001937896, 0001952194 & 0001962232, Jan-2027 Lots 0001981964, 0001981965, 0001994680 & 002012768, May 2027 Lot 0001998027, Jun 2027 Lot 002012787, Aug 2027Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
6/24/20267/7/20267/15/2026Class IIMethohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.Lot #: 10162261, 10162262, 10162279, 10162280, Exp. Date 07/21/2026; 10162314, 10162315, Exp. Date 07/22/2026; 10162465, 10162466, 10162491, 10162492, Exp. Date 07/26/2026; 10162542, 10162543, Exp. Date 07/27/2026; 10162559, 10162560, Exp. Date 07/28/2026; 10162623, 10162624, Exp. Date 07/29/2026; 10162693, 10162694, Exp. Date 07/30/2026; 10162735, 10162736, 10162753, 10162754, Exp. Date 07/31/2026; 10162772, 10162773, 10162791, 10162792, 10162810, 10162811, Exp. Date 08/02/2026; 10162820, Exp. Date 08/03/2026; 10162853, 10162854, Exp. Date 08/04/2026; 10163046, Exp. Date 08/09/2026; 10163156, 10163157, Exp. Date 08/10/2026.Failed Impurities/Degradation Specifications
6/24/20267/8/20267/15/2026Class IIPemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028Lack of Sterility Assurance
6/24/20267/8/20267/15/2026Class IIPemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;Lack of Sterility Assurance
6/24/20267/8/20267/15/2026Class IIBortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028Lack of Sterility Assurance
6/24/20267/8/20267/15/2026Class IIAzacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027Lack of Sterility Assurance
6/4/20266/30/20267/8/2026Class IIprednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIALots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Expires: 10/31/2026; HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298, Expires: 11/30/2026; HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, HB00043, Expires: 12/31/2026; HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, HB00084, Expires: 1/31/2027; HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, HB00200, Expires: 2/28/2027; HB00224, HB00226, HB00228, HB00230, HB00240, HB00242, Expires: 3/31/2027; HB00416, HB00417, HB00419, HB00439, HB00441, HB00443, HB00463, HB00465, Expires: 5/31/2027; HB00561, Expires: 6/30/2027; HB00569, HB00657, HB00659, HB00663, HB00671, HB00673, HB00675, HB00677, HB00679, Expires: 10/31/2027; HB00747, HB00749, HB00751, HB00753, Expires: 11/30/2027; HB00761, HB00763, HB00765, HB00783, HB00785, HC00002, HC00004, HC00006, HC00018, HC00020, HC00028, Expires: 12/31/2027; HC00030, HC00032, Expires: 1/31/2028; HC00056, HC00058, HC00062, HC00064, HC00073, HC00075, HC00079, HC00081, HC00083, Expires: 2/29/2028; HC00091, Expires: 3/31/2028; b) HA00945, HA00947, HA00949, Expires: 7/31/2026; HA01160, HA01162, HA01164, Expires: 10/31/2026; HA01234, HA01300, HA01302, Expires: 11/30/2026; HB00053, HB00055, HB00057, Expires: 1/31/2027; HB00107, HB00109, HB00111, HB00151, HB00153, HB00155, Expires: 2/28/2027; HB00386, HB00388, HB00390, HB00445, HB00447, Expires: 5/31/2027; HB00549, HB00551, HB00553, HB00555, Expires: 6/30/2027; HB00700, HB00702, Expires: 10/31/2027; HB00771, Expires: 11/30/2027; HC00008, HC00010, Expires: 12/31/2027; HC00034, HC00038, HC00054, HC00060, Expires: 1/31/2028; c) HA00951, HA00953, HA00955, Expires: 7/31/2026; HA01188, HA01190, HA01192, Expires: 10/31/2026; HA01304, Expires: 11/30/2026; HB00113, HB00115, Expires: 1/31/2027; HB00166, HB00168, Expires: 2/28/2027; HB00392, HB00394, HB00396, Expires:5/31/2027; HB00545, HB00547, Expires: 6/30/2027; HB00704, Expires: 10/31/2027; HB00773, Expires: 11/30/2027; HC00012, HC00014, Expires: 12/31/2027; HC00066, HC00068, Expires: 2/29/2028.Presence of Foreign Substance
6/8/20266/30/20267/8/2026Class IILevothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.Lot # D2401522, Exp Date: 06/2026.Subpotent Drug
6/8/20267/2/20267/8/2026Class IIAccucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028.Lack of Assurance of Sterility
6/8/20267/2/20267/8/2026Class IILidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.Lack of Assurance of Sterility
6/10/20266/29/20267/8/2026Class IIIMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.Lot # 004L24A, Exp Date: 02/19/2027.Lack of assurance of Sterility:
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co. Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIBD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42. Lot: 4298581, expires: 09/30/2026.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 5338383, Exp.11/30/2028, 5343740, 6008264, Exp. 12/31/2028, 6009889, 6031246, 6033968, Exp. 1/31/2029, 6041203, 6059301, 6061876, Exp. 2/28/2029, (b) 3293904, Exp. 10/31/2026, 3333265, Exp. 11/30/2026, 4031672, 1/31/2027, 4061583, 4068589, Exp. 2/28/2027, 4081770, Exp. 3/31/2027, 4154588, 4166005, Exp. 5/31/2027, 4213945, 4215736, Exp. 7/31/2027, 4241055, Exp. 8/31/2027, 4262802, 4270628, Exp. 9/30/2027, 4309640, Exp. 10/31/2027, 5114931, Exp. 4/30/2028, 5135055, 5136752, 5143453, Exp. 5/31/2028, 5165652, Exp. 6/30/2028.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227747, 4250845, Exp 08/31/2027, 50872610, 5093809, Exp 03/31/2028, 5121323, Exp 04/30/2028. b) 3331331, Exp 11/30/2026, 4284935, Exp 10/31/2027, 4344682, Exp 11/30/2027, 5015852, Exp 01/31/2028, 5086227, Exp 03/31/2028.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028.Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelBD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination | FDA
6/11/20266/29/20267/8/2026Class IIBD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS. Lot: 4190081, Exp 06/30/2027Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
6/12/20266/30/20267/8/2026Class IISynjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45Lot 3244413; Exp. 12/31/2028CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
6/26/20267/2/20267/8/2026Class IIDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.Lot#: 25285401A, Exp. Date: 04/2027Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
6/29/20267/2/20267/8/2026Class IICinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02Lot #: 5PB0165, 5PB0166, Exp 1/31/2027cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
4/8/20267/16/20267/8/2026Class IRevitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.Lot#: BL3608, Exp. 07/01/28.Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis.Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination | FDA
4/8/20267/16/20267/8/2026Class IITRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.Lot #: BL3435, Exp. 11/06/26CGMP Deviations: Failure to adequately investigate multiple stability failures
4/8/20267/16/20267/8/2026Class IITRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01. Lot #BL3411R, Exp 6/8/2027CGMP Deviations: the firm discontinued required stability testing for products on the market still within expiry
4/8/20267/16/20267/8/2026Class IITERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01. Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.CGMP Deviations: Failure to adequately investigate multiple stability failures
4/8/20267/16/20267/8/2026Class IITERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.CGMP Deviations: Failure to adequately investigate multiple stability failures
4/8/20267/16/20267/8/2026Class IIRevitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347- 120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670, Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27CGMP Deviations: Manufactured under the same conditions as product found to be contaminatedBlaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination | FDA
6/10/20267/21/20267/8/2026Class IIGemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01Lot #: CB0046, Exp. Date 06/2027Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
6/23/20267/21/20267/8/2026Class IIGlucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027.CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
5/28/20266/25/20267/1/2026Class IBD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.Lot # 4032183, Exp 01/31/2027Non-Sterility: Due to presence of Aspergillus penicillioides.BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination | FDA
5/28/20266/25/20267/1/2026Class IBD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.Lot # 4073005, Exp 03/31/2027Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination | FDA
6/4/20266/23/20267/1/2026Class IICorlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. a) Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027 b) Lot #1138201, 1138202, 08/31/2026, 1138900, 1141143, Exp. Date 08/31/2026; 1140280, 1140281, 1142063, Exp. Date 10/31/2026; 1142062, 1142942, 1142943, Exp. Date 11/30/2026; 1144081, 1144104, Exp. Date 12/31/2026; 1146373, 1146374, Exp. Date 01/31/2027; 1147491, 1147492, 1149843, Exp. Date 03/31/2027; 1151113, 1151890, 1153401, Exp. Date 07/31/2027; 1151114, 1151115, Exp. Date 09/30/2027; 1152412, 1153399, 1153400, Exp. Date 06/30/2027; 1155834, 1155835, Exp. Date 04/30/2027; 1155836, Exp. Date 09/30/2027; 1158480, 1158481, 1158482, Exp. Date 10/31/2027; 1160354, 1160355, Exp. Date 03/31/2028; 1161593, 1161594, 1161595, Exp. Date 04/30/2028; 1164097, 1164098, 1164099, Exp. Date 06/30/2028; 1165078, 1165079, Exp Date 07/31/2028; 1165080, Exp. Date 02/29/2028;1168005, 1168006, 1168007, Exp. Date 09/30/2028; 1169288, 1169289, Exp. Date 10/31/2028; 1172885, Exp. Date 12/31/2028.Presence of Foreign Substance.
6/4/20266/23/20267/1/2026Class IISensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 Lot#: 1156858, Exp. Date 12/31/2027.CGMP Deviations
6/4/20266/23/20267/1/2026Class IISensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 Lot #: 1157055, Exp. Date 1/31/2028CGMP Deviations
6/4/20266/23/20267/1/2026Class IICorlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028Presence of Foreign Substance.
6/4/20266/23/20267/1/2026Class IISensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 Lot #: 1157056, Exp. Date 02/29/2028CGMP Deviations
5/28/20266/25/20267/1/2026Class IIBD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4038825, 4038826, 4043641, 4045863, 4046559, Exp Date: 1/31/2027; Lot # 4049128, 4060484, 4061622, 4062534, Exp Date: 02/28/2027; Lot # 4072323, 4081465, 4092172, 4092053, 4092057, 4093448, 4096267, 4099351, Exp Date: 03/31/2027; Lot # 4106830, 4106833, 4106834, 4123769, 4123637, 4124547, 4123599, 4131749, Exp Date: 04/30/2027; Lot # 4137704, 4139447, Exp Date: 05/31/2027Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination | FDA
5/28/20266/25/20267/1/2026Class IIBD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 3293922, 3297295, 3298930, 3299555, 3299562, 3301403, 3304245, 3306751, 3307190, 3310919, 3310926, 3314371, Exp Date: 10/31/2026; Lot # 3319520, 3321408, 3321409, 3324363, 3324369, 3332082, 3334305, 3335243, 3336896, 3337416, 3337417, 3340134, 3343540, 3346461, Exp Date: 11/30/2026; Lot # 3347121, 3350902, 3353143, 4004043, 4008394, 4009336, 4011488, 4012213, Exp Date: 12/31/2026; Lot # 4017668, 4019659, 4024538, 4025597, 4028103, 4030830, 4031885, 4032130, 4034194, 4037955, 4039988, 4039341, 4042520, 4045073, Exp Date: 01/31/2027; Lot # 4045127, 4050288, 4053896, 4058398, 4060624, 4062561, 4066133, 4068918, 4070112, 4074981, 4075814, 4078276, Exp Date: 02/28/2027; Lot # 4072390, 4073005, 4079088, 4080879, 4081625, 4086628, 4087806, 4096981, 4100347, 4100349, 4103385, 4103386, 4110975, 4113747, 4131843, Exp Date: 03/31/2027; Lot # 4121050, 4123171, 4123172, 4128501, 4128502, 4130512, 4135272, Exp Date: 04/30/2027; Lot # 4141597, 4150024, 4149611, 4150025, 4152202, 4157691, 4159978, 4160566, 4163121, Exp Date: 05/31/2027; Lot # 4173445, 4173447, 4178299, 4178303, 4180764, 4193574, 4197392, 4200111, 4204425, Exp Date: 06/30/2027; Lot # 4205156, 4206764, 4206766, 4207230, 4213335, 4211319, 4215668, 4218795, 4220980, 4242090, Exp Date: 07/31/2027; Lot # 4226396, 4227235, 4229934, 4232786, 4236636, 4236982, 4236489, 4242092, 4242505, 4248359, 4250795, 4254763, Exp Date: 08/31/2027; Lot # 4256132, 4260191, 4261289, 4261760, 4262812, 4269519, 4270776, 4271977, 4274445, 4276054, 4282861, Exp Date: 09/30/2027; Lot # 4284334, 4290362, 4291615, 4297871, 4299657, 4300686, 4302997, 4303204, 4305323, 4305318, 4310195, 4311615, 4312855, 4313930, Exp Date: 10/31/2027.Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination | FDA
5/28/20266/22/20267/1/2026Class IIFenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.Lot # PA02216; Exp. 12/2029CGMP Deviations
6/4/20266/25/20267/1/2026Class IIPovi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026.sub potency
6/4/20266/25/20267/1/2026Class IILacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.Lot: A253999, A254000, Expires: 09/30/2027.Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
6/16/20266/22/20267/1/2026Class IICarton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10. Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.Subpotent Drug
6/17/20266/26/20267/1/2026Class IIPerampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6Lot AE01763, Expires 9/30/2027.Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
6/22/20266/23/20267/1/2026Class IIDULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
5/15/20266/12/20266/24/2026Class IIVistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.Lot #: AE001, expires: 5/31/2026.Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
5/15/20266/12/20266/24/2026Class IIVistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.Lot #: AE001, expires: 5/31/2026.Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
5/15/20266/12/20266/24/2026Class IIVistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.Lot #: AE006, expires: 5/31/2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
5/15/20266/12/20266/24/2026Class IIVistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.Lot #: AH001, expires: 8/31/2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
5/18/20266/12/20266/24/2026Class IIVasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.Lot#: 20260327VAS-3, BUD: 05/26/2026; 20260320VAS-3, BUD: 05/19/2026.Subpotent Drug
5/27/20266/16/20266/24/2026Class IIAripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.Lot: PA00805, expires: 01/31/2029Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
5/21/20266/18/20266/24/2026Class IIPearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.BNZ-001917, Exp 04/01/2029Defective container:may contain bottles with incomplete seals
5/21/20266/18/20266/24/2026Class IIQuala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.BNZ-001921, EXP 04/15/2029Defective container:may contain bottles with incomplete seals
5/21/20266/18/20266/24/2026Class IIDHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30BNZ-001921, EXP 04/15/2029Defective container:may contain bottles with incomplete seals
5/21/20266/18/20266/24/2026Class IIBurkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30BNZ-001917, Exp 04/15/2029Defective container:may contain bottles with incomplete seals
5/21/20266/18/20266/24/2026Class IIDental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30BNZ-001921, Exp 04/15/2029Defective container:may contain bottles with incomplete seals
5/21/20266/18/20266/24/2026Class IIPureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30BNZ-001921, EXP 04/15/2029Defective container:may contain bottles with incomplete seals
5/21/20266/18/20266/24/2026Class IIsafco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.BNZ-001921, Exp 04/15/2029Defective container:may contain bottles with incomplete seals
5/27/20266/12/20266/24/2026Class IIAlyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
6/5/20266/22/20266/24/2026Class IIChlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027Failed Dissolution Specifications
6/12/20266/17/20266/24/2026Class IIBuprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027Crystallization; identified as Buprenorphine free base
5/12/20266/5/20266/17/2026Class IDOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.Lot HAG2581B, expires: 05/31/2027Presence of Particulate matter: Particulate matter identified as glass.Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles | FDA
6/4/20266/8/20266/17/2026Class IIDuloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10Lot: 241180C, Exp. Date April 2027.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
6/4/20266/8/20266/17/2026Class IIDuloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
5/22/20266/10/20266/17/2026Class IIZep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85.Batch # E2612116, Exp Date: April 2029.Microbial contamination of sterile products
5/29/20266/11/20266/17/2026Class IIGSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
5/29/20266/18/20266/17/2026Class IIBudesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.Lot #: BAG0074A, Exp. Date: 1/31/2027.Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
6/1/20266/17/20266/17/2026Class IIMinocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30Lot# 25141635, Exp 4/30/2028Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
5/5/20266/2/20266/10/2026Class IIAmlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.Lot: 24123460, Expires: October 31, 2027.Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
5/12/20266/2/20266/10/2026Class IILidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.Lack of Assurance of Sterility
5/14/20266/2/20266/10/2026Class IIDuloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
5/28/20266/3/20266/10/2026Class IIKIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80Lot#: 1716059, 1716060, 1716061, 1716062, 1716063, 1716218, 1716219, 1716228, 1716229, 1716238, Exp 2/28/2029; 1716258, Exp 3/31/2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIGood Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80.Lot #: 1276118, Exp 1/31/2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIGood Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23.Lot #: 1716089, Exp 1/31/2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IICAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.Lot #: 1276118, 1276119, expires: JAN 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IICAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.Lot #: 1716259, Exp 3/31/2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIFAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68.Lot #: 1716089, expires: JAN 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIH.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22.Lot #: 1276118, expires: JAN 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIGOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.Lot #: 1276118, expires: JAN- 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIGOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.Lot #: 1716089, expires: JAN- 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIEQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.Lot #: 1276118, expires: JAN- 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IIEQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.Lot #: 1716089, expires: JAN- 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IITopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22.Lot #: 1276119, expires: JAN- 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/28/20266/3/20266/10/2026Class IITopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68.Lot #: 1716089, expires: JAN- 2029.Presence of foreign substance: small metallic particles in chewable tablets.
5/22/20266/18/20266/10/2026Class IIXyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10Lot #: AD93852, Exp Date: 06/2027.Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
5/22/20266/18/20266/10/2026Class IIXyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10Lot #: AE11393, Exp Date: 10/2027.Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
5/27/20266/10/20266/10/2026Class IINiacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.Lot #: 25282724A, Exp. Date 2027/01Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
4/24/20265/19/20265/27/2026Class IILiraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.Presence of particulate matter: a white thread-like structure in the cartridge
4/29/20265/20/20265/27/2026Class IIErythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
4/29/20265/20/20265/27/2026Class IIErythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
4/30/20265/18/20265/27/2026Class IIAtomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01Lot #: 25530722Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
5/1/20265/21/20265/27/2026Class IIVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026Presence of a Foreign Substance; black particles observed in liquid
5/11/20265/19/20265/27/2026Class IIGas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
5/8/20265/20/20265/27/2026Class IIcimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-22; CWNDS, Exp.: 2026-DEC-11.Lack of Assurance of Sterility
5/12/20265/20/20265/27/2026Class IIEstradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20Lot M251109, exp Nov 2027Defective Container; packets were found to be either empty or partially full.
5/12/20265/21/20265/27/2026Class IIfentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.Lot#: 20260310FEN-1, Exp. Date: 09/06/2026Subpotent Drug
4/24/20265/29/20265/27/2026Class IMG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.Lot #: 1024088, Exp 11/30/2026Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.Pharmacal Issues Nationwide Recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream Due to Microbial Contamination | FDA
3/13/20265/11/20265/20/2026Class IIBuprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027Presence of particulate matter: identified as Buprenorphine free base
4/27/20265/8/20265/20/2026Class IIOasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1.Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26.Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
4/27/20265/20/20265/20/2026Class IIAscend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.Lot # 25140859; Exp. Date: Jan 2027Failed Dissolution Failure
5/23/20255/5/20265/13/2026Class IIRika Plasma Donation System, Model Number: 42000 Apheresis System - Separator, Automated, Blood Cell, Diagnostic Lot Numbers: N/A Primary DI Number: 0502058342007 Serial Numbers: Serial Number 1J00307 1J00310 1J00315 1J00316 1J00319 1J00322 1J00324 1J00326 1J00328 1J00332 1J00333 1J00335 1J00336 1J00337 1J00338 1J00339 1J00340 1J00341 1J00342 1J00344 1J00345 1J00346 1J00347 1J00348 1J00349 1J00351 1J00353 1J00354 1J00358 1J00359 1J00361 1J00363 1J00366 1J00368 1J00369 1J00370 1J00371 1J00374 1J00375 1J00376 1J00377 1J00378 1J00380 1J00382 1J00383 1J00384 1J00387 1J00388 1J00390 1J00393 1J00394 1J00396 1J00397 1J00401 1J00403 1J00405 1J00406 1J00407 1J00408 1J00409 1J00410 1J00412 1J00413 1J00415 1J00416 1J00417 1J00418 1J00421 1J00422 1J00424 1J00425 1J00427 1J00428 1J00434 1J00441 1J00442 1J00445 1J00448 1J00451 1J00453 1J00457 1J00460 1J00461 1J00463 1J00464 1J00466 1J00468 1J00469 1J00473 1J00475 1J00476 1J00477 1J00479 1J00482 1J00483 1J00484 1J00486 1J00487 1J00488 1J00491 1J00493 1J00495 1J00496 1J00497 1J00498 1J00499 1J00501 1J00504 1J00506 1J00509 1J00510 1J00513 1J00518 1J00519 1J00520 1J00524 1J00525 1J00526 1J00527 1J00529 1J00533 1J00534 1J00535 1J00536 1J00537 1J00538 1J00540 1J00541 1J00542 1J00543 1J00544 1J00545 1J00548 1J00549 1J00551 1J00555 1J00557 1J00558 1J00562 1J00563 1J00565 1J00567 1J00568 1J00569 1J00570 1J00571 1J00573 1J00577 1J00580 1J00581 1J00583 1J00586 1J00587 1J00588 1J00589 1J00591 1J00593 1J00594 1J00595 1J00596 1J00598 1J00599 1J00600 1J00601 1J00602 1J00603 1J00604 1J00606 1J00610 1J00611 1J00614 1J00617 1J00618 1J00621 1J00624 1J00630 1J00631 1J00634 1J00635 1J00636 1J00637 1J00638 1J00639 1J00640 1J00641 1J00642 1J00644 1J00646 1J00648 1J00650 1J00651 1J00652 1J00654 1J00655 1J00657 1J00658 1J00659 1J00660 1J00664 1J00665 1J00667 1J00668 1J00677 1J00679 1J00680 1J00681 1J00682 1J00684 1J00687 1J00691 1J00692 1J00693 1J00694 1J00696 1J00698 1J00699 1J00702 1J00703 1J00705 1J00709 1J00714 1J00716 1J00717 1J00719 1J00721 1J00723 1J00724 1J00726 1J00727 1J00729 1J00731 1J00732 1J00733 1J00735 1J00736 1J00737 1J00738 1J00739 1J00742 1J00745 1J00747 1J00748 1J00750 1J00751 1J00752 1J00753 1J00754 1J00757 1J00758 1J00759 1J00760 1J00761 1J00763 1J00765 1J00766 1J00767 1J00768 1J00769 1J00770 1J00772 1J00776 1J00779 1J00780 1J00781 1J00783 1J00784 1J00785 1J00786 1J00788 1J00790 1J00793 1J00794 1J00795 1J00796 1J00799 1J00800 1J00806 1J00808 1J00809 1J00811 1J00812 1J00813 1J00814 1J00815 1J00816 1J00817 1J00818 1J00819 1J00820 1J00821 1J00822 1J00823 1J00824 1J00825 1J00826 1J00827 1J00830 1J00832 1J00833 1J00834 1J00835 1J00836 1J00837 1J00839 1J00840 1J00841 1J00844 1J00847 1J00848 1J00849 1J00851 1J00853 1J00854 1J00855 1J00856 1J00858 1J00860 1J00861 1J00864 1J00865 1J00866 1J00868 1J00869 1J00870 1J00871 1J00872 1J00873 1J00874 1J00875 1J00876 1J00877 1J00878 1J00881 1J00883 1J00885 1J00887 1J00891 1J00893 1J00894 1J00896 1J00897 1J00898 1J00899 1J00900 1J00901 1J00902 1J00904 1J00905 1J00907 1J00908 1J00909 1J00910 1J00912 1J00913 1J00915 1J00916 1J00917 1J00919 1J00920 1J00922 1J00923 1J00926 1J00927 1J00931 1J00934 1J00936 1J00937 1J00939 1J00940 1J00942 1J00943 1J00945 1J00946 1J00947 1J00949 1J00951 1J00952 1J00954 1J00955 1J00956 1J00957 1J00959 1J00960 1J00961 1J00962 1J00964 1J00965 1J00967 1J00969 1J00970 1J00972 1J00973 1J00974 1J00975 1J00976 1J00978 1J00979 1J00980 1J00982 1J00985 1J00986 1J00987 1J00988 1J00990 1J00993 1J00996 1J01001 1J01002 1J01004 1J01005 1J01006 1J01007 1J01009 1J01010 1J01011 1J01012 1J01013 1J01014 1J01015 1J01019 1J01021 1J01023 1J01024 1J01025 1J01026 1J01028 1J01029 1J01030 1J01031 1J01033 1J01034 1J01035 1J01037 1J01038 1J01040 1J01043 1J01044 1J01045 1J01046 1J01047 1J01049 1J01050 1J01051 1J01052 1J01053 1J01055 1J01056 1J01057 1J01060 1J01061 1J01062 1J01063 1J01065 1J01066 1J01067 1J01068 1J01071 1J01072 1J01073 1J01074 1J01075 1J01077 1J01079 1J01081 1J01082 1J01084 1J01086 1J01087 1J01088 1J01089 1J01090 1J01092 1J01094 1J01095 1J01097 1J01099 1J01100 1J01102 1J01103 1J01104 1J01106 1J01107 1J01108 1J01113 1J01124 1J01126 1J01129 1J01131 1J01132 1J01133 1J01134 1J01135 1J01137 1J01139 1J01141 1J01142 1J01143 1J01144 1J01146 1J01147 1J01149 1J01151 1J01152 1J01154 1J01159 1J01162 1J01163 1J01164 1J01165 1J01166 1J01167 1J01168 1J01169 1J01171 1J01173 1J01175 1J01176 1J01178 1J01180 1J01181 1J01183 1J01185 1J01188 1J01190 1J01191 1J01192 1J01194 1J01195 1J01198 1J01201 1J01202 1J01204 1J01206 1J01207 1J01208 1J01210 1J01211 1J01212 1J01214 1J01215 1J01216 1J01218 1J01219 1J01220 1J01222 1J01224 1J01225 1J01226 1J01227 1J01229 1J01230 1J01231 1J01233 1J01234 1J01235 1J01236 1J01237 1J01239 1J01240 1J01241 1J01242 1J01244 1J01245 1J01247 1J01248 1J01249 1J01250 1J01251 1J01252 1J01253 1J01254 1J01255 1J01256 1J01258 1J01259 1J01260 1J01261 1J01262 1J01263 1J01264 1J01266 1J01267 1J01268 1J01271 1J01272 1J01273 1J01274 1J01275 1J01276 1J01278 1J01280 1J01282 1J01283 1J01286 1J01287 1J01288 1J01289 1J01290 1J01292 1J01293 1J01294 1J01295 1J01296 1J01297 1J01298 1J01300 1J01301 1J01302 1J01303 1J01304 1J01305 1J01306 1J01307 1J01308 1J01310 1J01311 1J01312 1J01314 1J01315 1J01316 1J01317 1J01318 1J01321 1J01322 1J01323 1J01325 1J01327 1J01328 1J01329 1J01330 1J01331 1J01332 1J01333 1J01334 1J01335 1J01336 1J01337 1J01339 1J01340 1J01343 1J01345 1J01346 1J01347 1J01348 1J01349 1J01350 1J01351 1J01353 1J01354 1J01355 1J01356 1J01357 1J01358 1J01359 1J01360 1J01362 1J01363 1J01364 1J01366 1J01367 1J01368 1J01369 1J01370 1J01371 1J01373 1J01375 1J01376 1J01378 1J01379 1J01381 1J01382 1J01383 1J01384 1J01386 1J01388 1J01389 1J01391 1J01393 1J01394 1J01395 1J01396 1J01398 1J01400 1J01401 1J01402 1J01404 1J01405 1J01406 1J01408 1J01409 1J01410 1J01411 1J01412 1J01413 1J01414 1J01415 1J01416 1J01417 1J01418 1J01421 1J01423 1J01424 1J01425 1J01427 1J01428 1J01429 1J01431 1J01432 1J01434 1J01435 1J01437 1J01439 1J01440 1J01442 1J01444 1J01446 1J01447 1J01450 1J01451 1J01453 1J01454 1J01456 1J01459 1J01460 1J01462 1J01463 1J01466 1J01467 1J01468 1J01469 1J01471 1J01474 1J01475 1J01477 1J01478 1J01480 1J01481 1J01482 1J01483 1J01485 1J01486 1J01488 1J01489 1J01491 1J01494 1J01495 1J01497 1J01498 1J01501 1J01502 1J01503 1J01504 1J01505 1J01506 1J01507 1J01509 1J01510 1J01512 1J01513 1J01516 1J01517 1J01519 1J01520 1J01521 1J01522 1J01523 1J01524 1J01525 1J01526 1J01528 1J01532 1J01534 1J01536 1J01538 1J01540 1J01542 1J01543 1J01545 1J01546 1J01547 1J01549 1J01550 1J01551 1J01553 1J01554 1J01556 1J01557 1J01559 1J01560 1J01561 1J01562 1J01563 1J01564 1J01566 1J01567 1J01568 1J01569 1J01570 1J01571 1J01572 1J01574 1J01576 1J01577 1J01579 1J01580 1J01581 1J01582 1J01583 1J01584 1J01586 1J01588 1J01589 1J01591 1J01593 1J01594 1J01595 1J01596 1J01597 1J01598 1J01599 1J01600 1J01601 1J01602 1J01604 1J01606 1J01607 1J01609 1J01611 1J01612 1J01614 1J01616 1J01617 1J01619 1J01620 1J01623 1J01624 1J01626 1J01627 1J01629 1J01631 1J01632 1J01633 1J01634 1J01636 1J01637 1J01640 1J01641 1J01643 1J01647 1J01648 1J01649 1J01650 1J01651 1J01652 1J01654 1J01656 1J01657 1J01659 1J01660 1J01661 1J01662 1J01663 1J01664 1J01665 1J01667 1J01668 1J01670 1J01671 1J01673 1J01675 1J01676 1J01678 1J01679 1J01680 1J01682 1J01683 1J01684 1J01685 1J01686 1J01688 1J01689 1J01690 1J01691 1J01692 1J01693 1J01694 1J01695 1J01698 1J01700 1J01703 1J01704 1J01709 1J01711 1J01712 1J01714 1J01715 1J01716 1J01717 1J01718 1J01720 1J01722 1J01723 1J01724 1J01725 1J01726 1J01729 1J01730 1J01731 1J01732 1J01735 1J01738 1J01740 1J01743 1J01745 1J01746 1J01747 1J01748 1J01749 1J01751 1J01752 1J01753 1J01755 1J01757 1J01758 1J01760 1J01761 1J01763 1J01765 1J01766 1J01768 1J01770 1J01771 1J01772 1J01774 1J01775 1J01776 1J01777 1J01778 1J01779 1J01780 1J01782 1J01783 1J01784 1J01786 1J01788 1J01790 1J01792 1J01793 1J01794 1J01796 1J01797 1J01799 1J01802 1J01803 1J01804 1J01805 1J01807 1J01808 1J01809 1J01812 1J01813 1J01815 1J01816 1J01817 1J01819 1J01822 1J01823 1J01824 1J01825 1J01827 1J01828 1J01829 1J01830 1J01832 1J01833 1J01835 1J01836 1J01838 1J01840 1J01841 1J01842 1J01843 1J01844 1J01845 1J01846 1J01847 1J01849 1J01850 1J01851 1J01852 1J01853 1J01854 1J01855 1J01856 1J01857 1J01858 1J01859 1J01861 1J01863 1J01865 1J01866 1J01867 1J01868 1J01869 1J01870 1J01871 1J01872 1J01873 1J01874 1J01875 1J01877 1J01879 1J01880 1J01882 1J01884 1J01886 1J01887 1J01888 1J01890 1J01891 1J01893 1J01895 1J01896 1J01897 1J01898 1J01899 1J01900 1J01903 1J01904 1J01906 1J01907 1J01908 1J01910 1J01911 1J01912 1J01913 1J01915 1J01916 1J01920 1J01921 1J01922 1J01923 1J01925 1J01927 1J01928 1J01930 1J01932 1J01933 1J01934 1J01937 1J01939 1J01940 1J01944 1J01946 1J01949 1J01950 1J01952 1J01954 1J01955 1J01956 1J01957 1J01959 1J01961 1J01962 1J01966 1J01970 1J01973 1J01975 1J01976 1J01977 1J01982 1J01983 1J01985 1J01990 1J01991 1J01992 1J01993 1J01994 1J01996 1J01997 1J01999 1J02000 1J02001 1J02002 1J02004 1J02006 1J02007 1J02009 1J02010 1J02011 1J02012 1J02013 1J02014 1J02015 1J02018 1J02019 1J02020 1J02023 1J02024 1J02025 1J02026 1J02027 1J02028 1J02029 1J02030 1J02031 1J02032 1J02033 1J02034 1J02036 1J02037 1J02038 1J02039 1J02040 1J02041 1J02042 1J02043 1J02044 1J02046 1J02047 1J02048 1J02049 1J02050 1J02052 1J02053 1J02054 1J02055 1J02056 1J02057 1J02058 1J02059 1J02060 1J02061 1J02062 1J02063 1J02064 1J02065 1J02066 1J02067 1J02068 1J02070 1J02071 1J02072 1J02073 1J02074 1J02075 1J02076 1J02077 1J02078 1J02079 1J02080 1J02081 1J02082 1J02083 1J02084 1J02085 1J02086 1J02087 1J02088 1J02089 1J02090 1J02091 1J02092 1J02093 1J02094 1J02095 1J02096 1J02097 1J02098 1J02099 1J02100 1J02101 1J02102 1J02103 1J02104 1J02105 1J02106 1J02107 1J02108 1J02109 1J02110 1J02111 1J02112 1J02113 1J02114 1J02115 1J02117 1J02118 1J02119 1J02120 1J02121 1J02122 1J02123 1J02124 1J02125 1J02126 1J02127 1J02128 1J02129 1J02130 1J02131 1J02132 1J02133 1J02134 1J02135 1J02136 1J02137 1J02138 1J02139 1J02140 1J02141 1J02142 1J02143 1J02144 1J02145 1J02146 1J02148 1J02149 1J02150 1J02151 1J02152 1J02153 1J02154 1J02155 1J02156 1J02157 1J02158 1J02159 1J02160 1J02161 1J02162 1J02163 1J02164 1J02165 1J02167 1J02169 1J02170 1J02171 1J02172 1J02173 1J02174 1J02175 1J02176 1J02177 1J02178 1J02179 1J02180 1J02181 1J02182 1J02183 1J02186 1J02188 1J02189 1J02190 1J02191 1J02192 1J02194 1J02195 1J02196 1J02197 1J02198 1J02199 1J02200 1J02201 1J02202 1J02203 1J02204 1J02205 1J02206 1J02207 1J02208 1J02209 1J02210 1J02211 1J02212 1J02213 1J02214 1J02215 1J02216 1J02218 1J02219 1J02220 1J02221 1J02222 1J02223 1J02224 1J02225 1J02226 1J02229 1J02230 1J02231 1J02232 1J02233 1J02234 1J02235 1J02236 1J02237 1J02238 1J02239 1J02240 1J02241 1J02242 1J02243 1J02245 1J02246 1J02247 1J02248 1J02249 1J02250 1J02251 1J02252 1J02253 1J02254 1J02255 1J02256 1J02257 1J02258 1J02259 1J02260 1J02261 1J02262 1J02263 1J02264 1J02265 1J02266 1J02267 1J02268 1J02269 1J02270 1J02271 1J02272 1J02273 1J02274 1J02275 1J02276 1J02277 1J02278 1J02279 1J02280 1J02281 1J02282 1J02283 1J02284 1J02285 1J02286 1J02287 1J02288 1J02289 1J02290 1J02291 1J02292 1J02294 1J02296 1J02297 1J02298 1J02299 1J02300 1J02301 1J02302 1J02303 1J02304 1J02305 1J02306 1J02307 1J02308 1J02309 1J02310 1J02311 1J02312 1J02313 1J02314 1J02315 1J02316 1J02317 1J02318 1J02319 1J02320 1J02321 1J02322 1J02323 1J02324 1J02326 1J02327 1J02328 1J02329 1J02330 1J02331 1J02332 1J02333 1J02334 1J02335 1J02336 1J02337 1J02338 1J02339 1J02341 1J02342 1J02343 1J02344 1J02345 1J02346 1J02347 1J02348 1J02349 1J02350 1J02351 1J02352 1J02353 1J02354 1J02355 1J02356 1J02357 1J02358 1J02359 1J02360 1J02361 1J02362 1J02363 1J02364 1J02365 1J02366 1J02367 1J02368 1J02369 1J02370 1J02371 1J02372 1J02373 1J02374 1J02375 1J02376 1J02377 1J02378 1J02379 1J02380 1J02381 1J02382 1J02383 1J02384 1J02385 1J02386 1J02387 1J02388 1J02389 1J02390 1J02391 1J02392 1J02393 1J02394 1J02395 1J02396 1J02398 1J02399 1J02400 1J02401 1J02402 1J02403 1J02404 1J02405 1J02406 1J02407 1J02408 1J02409 1J02410 1J02411 1J02412 1J02413 1J02414 1J02415 1J02416 1J02417 1J02418 1J02419 1J02420 1J02421 1J02422 1J02423 1J02424 1J02425 1J02426 1J02427 1J02428 1J02429 1J02431 1J02432 1J02433 1J02434 1J02435 1J02436 1J02437 1J02438 1J02439 1J02440 1J02441 1J02442 1J02443 1J02444 1J02445 1J02446 1J02447 1J02448 1J02449 1J02450 1J02451 1J02452 1J02453 1J02454 1J02455 1J02456 1J02457 1J02458 1J02459 1J02460 1J02461 1J02462 1J02463 1J02464 1J02465 1J02466 1J02467 1J02468 1J02469 1J02470 1J02472 1J02473 1J02474 1J02475 1J02476 1J02477 1J02478 1J02479 1J02480 1J02481 1J02483 1J02484 1J02485 1J02486 1J02487 1J02488 1J02489 1J02490 1J02491 1J02492 1J02493 1J02494 1J02495 1J02496 1J02497 1J02498 1J02499 1J02500 1J02501 1J02504 1J02505 1J02506 1J02507 1J02508 1J02510 1J02511 1J02512 1J02513 1J02516 1J02517 1J02518 1J02519 1J02521 1J02522 1J02523 1J02524 1J02525 1J02526 1J02527 1J02528 1J02529 1J02530 1J02532 1J02533 1J02534 1J02535 1J02536 1J02537 1J02538 1J02539 1J02540 1J02541 1J02542 1J02543 1J02544 1J02545 1J02546 1J02547 1J02548 1J02549 1J02550 1J02551 1J02552 1J02553 1J02554 1J02555 1J02556 1J02557 1J02558 1J02559 1J02560 1J02561 1J02562 1J02563 1J02564 1J02565 1J02566 1J02567 1J02568 1J02569 1J02570 1J02571 1J02572 1J02573 1J02574 1J02576 1J02577 1J02578 1J02579 1J02580 1J02581 1J02582 1J02583 1J02584 1J02585 1J02586 1J02587 1J02588 1J02589 1J02590 1J02591 1J02592 1J02593 1J02594 1J02595 1J02596 1J02597 1J02598 1J02599 1J02600 1J02601 1J02603 1J02604 1J02605 1J02606 1J02607 1J02608 1J02609 1J02610 1J02611 1J02612 1J02613 1J02614 1J02615 1J02617 1J02618 1J02619 1J02620 1J02621 1J02622 1J02623 1J02624 1J02625 1J02626 1J02627 1J02629 1J02630 1J02631 1J02632 1J02633 1J02634 1J02635 1J02636 1J02637 1J02638 1J02639 1J02640 1J02641 1J02642 1J02643 1J02644 1J02646 1J02647 1J02648 1J02649 1J02650 1J02651 1J02652 1J02653 1J02654 1J02655 1J02656 1J02657 1J02658 1J02659 1J02660 1J02661 1J02662 1J02663 1J02664 1J02665 1J02666 1J02667 1J02668 1J02669 1J02670 1J02671 1J02672 1J02673 1J02674 1J02675 1J02676 1J02677 1J02678 1J02680 1J02681 1J02682 1J02683 1J02684 1J02685 1J02686 1J02687 1J02688 1J02689 1J02690 1J02691 1J02692 1J02693 1J02694 1J02695 1J02696 1J02697 1J02698 1J02699 1J02700 1J02701 1J02702 1J02703 1J02704 1J02705 1J02707 1J02708 1J02709 1J02710 1J02711 1J02712 1J02713 1J02715 1J02716 1J02717 1J02718 1J02719 1J02720 1J02721 1J02722 1J02723 1J02724 1J02725 1J02726 1J02727 1J02728 1J02729 1J02730 1J02731 1J02732 1J02733 1J02734 1J02735 1J02736 1J02737 1J02738 1J02739 1J02740 1J02741 1J02742 1J02743 1J02744 1J02745 1J02746 1J02747 1J02748 1J02749 1J02750 1J02752 1J02753 1J02754 1J02755 1J02756 1J02757 1J02759 1J02760 1J02761 1J02762 1J02763 1J02764 1J02765 1J02766 1J02767 1J02768 1J02769 1J02770 1J02771 1J02772 1J02773 1J02774 1J02776 1J02777 1J02778 1J02779 1J02780 1J02781 1J02782 1J02783 1J02784 1J02785 1J02786 1J02787 1J02788 1J02789 1J02790 1J02791 1J02792 1J02794 1J02795 1J02796 1J02797 1J02798 1J02799 1J02800 1J02801 1J02802 1J02803 1J02804 1J02805 1J02806 1J02807 1J02809 1J02810 1J02811 1J02812 1J02813 1J02814 1J02815 1J02816 1J02817 1J02818 1J02819 1J02820 1J02821 1J02822 1J02823 1J02824 1J02825 1J02826 1J02827 1J02829 1J02830 1J02831 1J02832 1J02833 1J02834 1J02835 1J02836 1J02837 1J02839 1J02840 1J02842 1J02843 1J02844 1J02845 1J02846 1J02848 1J02850 1J02851 1J02852 1J02853 1J02854 1J02855 1J02857 1J02858 1J02860 1J02862 1J02863 1J02864 1J02865 1J02866 1J02868 1J02870 1J02871 1J02872 1J02873 1J02874 1J02875 1J02876 1J02877 1J02878 1J02879 1J02880 1J02881 1J02882 1J02883 1J02884 1J02885 1J02886 1J02887 1J02888 1J02889 1J02890 1J02891 1J02892 1J02893 1J02894 1J02895 1J02896 1J02897 1J02898 1J02899 1J02900 1J02901 1J02902 1J02903 1J02904 1J02905 1J02906 1J02907 1J02908 1J02909 1J02910 1J02911 1J02912 1J02913 1J02914 1J02915 1J02916 1J02917 1J02918 1J02919 1J02920 1J02921 1J02922 1J02923 1J02924 1J02925 1J02926 1J02927 1J02928 1J02929 1J02930 1J02931 1J02932 1J02933 1J02934 1J02935 1J02936 1J02937 1J02938 1J02939 1J02940 1J02941 1J02942 1J02943 1J02944 1J02945 1J02946 1J02947 1J02948 1J02949 1J02950 1J02951 1J02952 1J02953 1J02954 1J02955 1J02956 1J02957 1J02958 1J02959 1J02960 1J02961 1J02962 1J02963 1J02964 1J02965 1J02966 1J02967 1J02968 1J02969 1J02970 1J02971 1J02972 1J02973 1J02974 1J02975 1J02976 1J02977 1J02978 1J02979 1J02980 1J02981 1J02982 1J02983 1J02984 1J02985 1J02986 1J02987 1J02988 1J02989 1J02990 1J02992 1J02993 1J02994 1J02995 1J02996 1J02997 1J02998 1J02999 1J03000 1J03001 1J03002 1J03003 1J03004 1J03005 1J03006 1J03007 1J03008 1J03009 1J03010 1J03011 1J03012 1J03013 1J03014 1J03015 1J03016 1J03017 1J03018 1J03019 1J03020 1J03021 1J03022 1J03023 1J03024 1J03025 1J03026 1J03027 1J03028 1J03029 1J03030 1J03031 1J03032 1J03033 1J03034 1J03035 1J03036 1J03037 1J03038 1J03039 1J03040 1J03041 1J03042 1J03043 1J03044 1J03045 1J03046 1J03047 1J03048 1J03049 1J03050 1J03051 1J03052 1J03053 1J03054 1J03062 1J03063 1J03064 1J03065 1J03066 1J03067 1J03069 1J03071 1J03072 1J03073 1J03074 1J03075 1J03076 1J03077 1J03078 1J03079 1J03080 1J03081 1J03082 1J03083 1J03084 1J03085 1J03086 1J03087 1J03088 1J03089 1J03090 1J03091 1J03092 1J03093 1J03094 1J03095 1J03096 1J03097 1J03098 1J03099 1J03100 1J03101 1J03102 1J03103 1J03104 1J03105 1J03106 1J03107 1J03108 1J03109 1J03110 1J03111 1J03112 1J03113 1J03114 1J03115 1J03116 1J03117 1J03118 1J03119 1J03120 1J03121 1J03122 1J03123 1J03124 1J03125 1J03126 1J03127 1J03128 1J03129 1J03130 1J03131 1J03132 1J03133 1J03134 1J03135 1J03136 1J03137 1J03138 1J03139 1J03140 1J03141 1J03142 1J03143 1J03144 1J03145 1J03146 1J03147 1J03148 1J03149 1J03150 1J03151 1J03152 1J03153 1J03154 1J03155 1J03156 1J03157 1J03158 1J03159 1J03160 1J03161 1J03162 1J03163 1J03164 1J03165 1J03166 1J03167 1J03168 1J03169 1J03170 1J03171 1J03172 1J03173 1J03174 1J03175 1J03176 1J03177 1J03178 1J03179 1J03180 1J03181 1J03182 1J03183 1J03184 1J03185 1J03186 1J03187 1J03188 1J03189 1J03190 1J03191 1J03192 1J03193 1J03194 1J03195 1J03196 1J03197 1J03198 1J03199 1J03200 1J03201 1J03202 1J03203 1J03204 1J03205 1J03206 1J03207 1J03208 1J03209 1J03210 1J03211 1J03212 1J03213 1J03214 1J03215 1J03216 1J03217 1J03218 1J03219 1J03220 1J03221 1J03222 1J03223 1J03224 1J03225 1J03226 1J03227 1J03228 1J03229 1J03230 1J03231 1J03232 1J03233 1J03234 1J03235 1J03236 1J03237 1J03238 1J03239 1J03240 1J03241 1J03242 1J03243 1J03244 1J03245 1J03246 1J03247 1J03248 1J03249 1J03250 1J03251 1J03252 1J03253 1J03254 1J03255 1J03256 1J03257 1J03258 1J03259 1J03260 1J03261 1J03262 1J03263 1J03264 1J03265 1J03266 1J03267 1J03268 1J03269 1J03270 1J03271 1J03272 1J03274 1J03275 1J03276 1J03277 1J03278 1J03279 1J03280 1J03281 1J03282 1J03283 1J03284 1J03285 1J03286 1J03287 1J03288 1J03289 1J03290 1J03291 1J03292 1J03293 1J03294 1J03295 1J03296 1J03297 1J03298 1J03299 1J03300 1J03302 1J03303 1J03304 1J03305 1J03307 1J03308 1J03309 1J03310 1J03311 1J03312 1J03313 1J03315 1J03316 1J03317 1J03318 1J03319 1J03320 1J03321 1J03322 1J03323 1J03324 1J03325 1J03326 1J03327 1J03328 1J03329 1J03336 1J03337 1J03338 1J03339 1J03340 1J03341 1J03342 1J03343 1J03344 1J03345 1J03347 1J03348 1J03349 1J03350 1J03351 1J03352 1J03353 1J03354 1J03355 1J03356 1J03357 1J03358 1J03359 1J03360 1J03361 1J03362 1J03363 1J03364 1J03365 1J03366 1J03367 1J03368 1J03369 1J03370 1J03371 1J03372 1J03373 1J03374 1J03375 1J03376 1J03377 1J03378 1J03379 1J03380 1J03381 1J03382 1J03383 1J03384 1J03385 1J03386 1J03387 1J03388 1J03389 1J03390 1J03391 1J03392 1J03393 1J03394 1J03395 1J03396 1J03397 1J03398 1J03399 1J03400 1J03401 1J03402 1J03403 1J03404 1J03405 1J03406 1J03407 1J03408 1J03409 1J03410 1J03411 1J03412 1J03413 1J03417 1J03418 1J03419 1J03420 1J03421 1J03422 1J03423 1J03424 1J03425 1J03426 1J03427 1J03428 1J03429 1J03430 1J03431 1J03432 1J03433 1J03434 1J03435 1J03436 1J03437 1J03438 1J03439 1J03440 1J03441 1J03443 1J03444 1J03445 1J03446 1J03447 1J03448 1J03449 1J03450 1J03451 1J03452 1J03453 1J03454 1J03455 1J03456 1J03457 1J03458 1J03460 1J03461 1J03462 1J03464 1J03465 1J03466 1J03467 1J03469 1J03470 1J03471 1J03472 1J03473 1J03474 1J03475 1J03476 1J03477 1J03478 1J03479 1J03480 1J03481 1J03483 1J03484 1J03485 1J03486 1J03487 1J03488 1J03489 1J03490 1J03492 1J03493 1J03494 1J03495 1J03496 1J03497 1J03498 1J03499 1J03500 1J03501 1J03502 1J03503 1J03504 1J03505 1J03506 1J03507 1J03508 1J03509 1J03510 1J03511 1J03512 1J03513 1J03514 1J03515 1J03516 1J03517 1J03518 1J03519 1J03520 1J03521 1J03522 1J03523 1J03524 1J03525 1J03526 1J03527 1J03528 1J03529 1J03530 1J03531 1J03532 1J03533 1J03534 1J03536 1J03537 1J03539 1J03541 1J03542 1J03543 1J03544 1J03545 1J03546 1J03547 1J03549 1J03550 1J03551 1J03553 1J03554 1J03555 1J03556 1J03557 1J03558 1J03560 1J03561 1J03562 1J03564 1J03566 1J03567 1J03568 1J03571 1J03572 1J03573 1J03574 1J03575 1J03576 1J03577 1J03578 1J03579 1J03580 1J03581 1J03582 1J03583 1J03584 1J03585 1J03587 1J03589 1J03591 1J03593 1J03597 1J03600 1J03603 1J03604 1J03605 1J03606 1J03607 1J03608 1J03609 1J03610 1J03611 1J03612 1J03613 1J03614 1J03615 1J03616 1J03617 1J03618 1J03619 1J03620 1J03621 1J03622 1J03623 1J03624 1J03625 1J03626 1J03627 1J03628 1J03629 1J03630 1J03631 1J03632 1J03633 1J03634 1J03635 1J03636 1J03637 1J03638 1J03639 1J03640 1J03641 1J03642 1J03643 1J03644 1J03650 1J03651 1J03652 1J03653 1J03654 1J03655 1J03656 1J03657 1J03658 1J03659 1J03660 1J03661 1J03665 1J03666 1J03671 1J03672 1J03673 1J03674 1J03675 1J03677 1J03678 1J03681 1J03682 1J03683 1J03684 1J03685 1J03686 1J03687 1J03688 1J03689 1J03690 1J03691 1J03692 1J03693 1J03694 1J03695 1J03696 1J03697 1J03698 1J03699 1J03700 1J03701 1J03702 1J03703 1J03704 1J03705 1J03706 1J03707 1J03709 1J03710 1J03712 1J03715 1J03719 1J03720 1J03721 1J03722 1J03723 1J03724 1J03726 1J04000 1J04001 1J04002 1J04003 1J04004 1J04005 1J04006 1J04007 1J04008 1J04009 1J04010 1J04011 1J04012 1J04013 1J04014 1J04015 1J04016 1J04017 1J04018 1J04019 1J04020 1J04021 1J04022 1J04023 1J04024 1J04065 1J04066 1J04067 1J04068 1J04071 1J04072 1J04074 1J04075 1J04076 1J04077 1J04078 1J04079 1J04080 1J04082 1J04083 1J04085 1J04088 1J04089 1J04091 1J04095 1J04096 1J04097 1J04098 1J04099 1J04106 1J04107 1J04108 1J04109 1J04113 1J04114 1J04115 1J04116 1J04117 1J04118 1J04121 1J04122 1J04123 1J04124 1J04125 1J04126 1J04127 1J04129 1J04130 1J04131 1J04132 1J04133 1J04134 1J04135 1J04136 1J04137 1J04138 1J04139 1J04142 1J04144 1J04145 1J04146 1J04147 1J04148 1J04149 1J04150 1J04157 1J04158 1J04160 1J04161 1J04162 1J04164 1J04165 1J04174 1J04175 1J04176 1J04177 1J04181 1J04182 1J04183 1J04184 1J04185 1J04189 1J04190 1J04191 1J04194 1J04203 1J04204 1J04206 1J04207 1J04208 1J04212 1J04213 1J04215 1J04216 1J04217 1J04218 1J04219 1J04224 1J04227 1J04228 1J04229 1J04230 1J04231 1J04233 1J04234 1J04235 1J04237 1J04238 1J04239 1J04240 1J04241 1J04242 1J04243 1J04244 1J04247 1J04248 1J04250 1J04251 1J04252 1J04253 1J04254 1J04255 1J04256 1J04258 1J04259 1J04262 1J04264 1J04265 1J04266 1J04271 1J04272 1J04273 1J04274 1J04275 1J04276 1J04277 1J04278 1J04279 1J04280 1J04282 1J04283 1J04284 1J04285 1J04287 1J04288 1J04290 1J04291 1J04292 1J04293 1J04297 1J04300 1J04301 1J04304 1J04305 1J04306 1J04307 1J04308 1J04309 1J04310 1J04311 1J04312 1J04313 1J04314 1J04315 1J04316 1J04317 1J04318 1J04319 1J04320 1J04323 1J04325 1J04326 1J04327 1J04329 1J04332 1J04333 1J04334 1J04335 1J04336 1J04337 1J04338 1J04339 1J04340 1J04341 1J04342 1J04343 1J04344 1J04345 1J04346 1J04347 1J04348 1J04349 1J04350 1J04351 1J04352 1J04354 1J04355 1J04356 1J04357 1J04358 1J04360 1J04361 1J04362 1J04363 1J04364 1J04365 1J04366 1J04367 1J04368 1J04369 1J04370 1J04372 1J04374 1J04375 1J04377 1J04379 1J04380 1J04381 1J04383 1J04385 1J04386 1J04387 1J04388 1J04389 1J04391 1J04392 1J04393 1J04394 1J04396 1J04397 1J04398 1J04399 1J04400 1J04401 1J04402 1J04403 1J04404 1J04405 1J04406 1J04407 1J04408 1J04409 1J04410 1J04411 1J04412 1J04413 1J04414 1J04415 1J04416 1J04417 1J04418 1J04419 1J04420 1J04421 1J04422 1J04423 1J04424 1J04426 1J04451 1J04452 1J04453 1J04454 1J04455 1J04456 1J04457 1J04460 1J04462 1J04463 1J04464 1J04465 1J04466 1J04467 1J04468 1J04469 1J04470 1J04471 1J04472 1J04473 1J04474 1J04475 1J04476 1J04477 1J04478 1J04479 1J04482 1J04483 1J04484 1J04485 1J04486 1J04487 1J04489 1J04490 1J04491 1J04492 1J04493 1J04494 1J04495 1J04496 1J04498 1J04499 1J04500 1J04501 1J04502 1J04504 1J04505 1J04506 1J04508 1J04509 1J04510 1J04511 1J04512 1J04513 1J04515 1J04516 1J04517 1J04518 1J04519 1J04520 1J04521 1J04522 1J04523 1J04525 1J04526 1J04527 1J04528 1J04531 1J04536 1J04537 1J04539 1J04541 1J04542 1J04543 1J04544 1J04545 1J04546 1J04547 1J04548 1J04549 1J04550 1J04551 1J04552 1J04553 1J04554 1J04555 1J04556 1J04557 1J04558 1J04559 1J04560 1J04561 1J04562 1J04563 1J04565 1J04566 1J04567 1J04568 1J04570 1J04571 1J04572 1J04573 1J04574 1J04575 1J04576 1J04577 1J04578 1J04579 1J04580 1J04582 1J04583 1J04584 1J04585 1J04586 1J04587 1J04588 1J04589 1J04590 1J04591 1J04592 1J04593 1J04594 1J04595 1J04597 1J04599 1J04600 1J04601 1J04602 1J04603 1J04604 1J04606 1J04607 1J04608 1J04609 1J04611 1J04612 1J04613 1J04614 1J04615 1J04616 1J04617 1J04618 1J04619 1J04620 1J04621 1J04622 1J04623 1J04624 1J04625 1J04626 1J04627 1J04628 1J04629 1J04630 1J04631 1J04632 1J04634 1J04635 1J04636 1J04638 1J04639 1J04641 1J04642 1J04643 1J04645 1J04646 1J04647 1J04648 1J04650 1J04651 1J04653 1J04654 1J04655 1J04656 1J04660 1J04661 1J04664 1J04666 1J04667 1J04668 1J04669 1J04670 1J04672 1J04673 1J04676 1J04677 1J04678 1J04679 1J04680 1J04681 1J04682 1J04683 1J04684 1J04685 1J04686 1J04687 1J04688 1J04689 1J04691 1J04692 1J04694 1J04695 1J04696 1J04697 1J04698 1J04699 1J04700 1J04701 1J04702 1J04703 1J04704 1J04705 1J04706 1J04707 1J04708 1J04710 1J04711 1J04712 1J04713 1J04714 1J04715 1J04716 1J04717 1J04718 1J04719 1J04721 1J04722 1J04723 1J04724 1J04725 1J04726 1J04727 1J04729 1J04730 1J04731 1J04732 1J04733 1J04735 1J04736 1J04737 1J04738 1J04739 1J04740 1J04741 1J04742 1J04743 1J04744 1J04745 1J04746 1J04747 1J04748 1J04749 1J04750 1J04751 1J04752 1J04753 1J04754 1J04755 1J04756 1J04757 1J04758 1J04759 1J04760 1J04761 1J04762 1J04763 1J04764 1J04767 1J04768 1J04769 1J04771 1J04772 1J04773 1J04774 1J04775 1J04777 1J04778 1J04780 1J04781 1J04782 1J04783 1J04784 1J04785 1J04786 1J04787 1J04788 1J04789 1J04790 1J04791 1J04792 1J04793 1J04794 1J04795 1J04796 1J04797 1J04798 1J04799 1J04800 1J04801 1J04802 1J04803 1J04804 1J04805 1J04806 1J04807 1J04808 1J04809 1J04810 1J04811 1J04812 1J04813 1J04814 1J04815 1J04816 1J04817 1J04818 1J04819 1J04821 1J04823 1J04824 1J04826 1J04828 1J04829 1J04830 1J04831 1J04832 1J04833 1J04835 1J04836 1J04837 1J04838 1J04839 1J04840 1J04843 1J04848 1J04849 1J04850 1J04851 1J04852 1J04853 1J04854 1J04855 1J04856 1J04857 1J04858 1J04859 1J04860 1J04861 1J04862 1J04864 1J04865 1J04866 1J04867 1J04868 1J04869 1J04870 1J04871 1J04872 1J04874 1J04875 1J04876 1J04878 1J04879 1J04880 1J04881 1J04882 1J04883 1J04884 1J04886 1J04888 1J04890 1J04892 1J04893 1J04894 1J04895 1J04897 1J04902 1J04903 1J04904 1J04905 1J04906 1J04907 1J04908 1J04909 1J04910 1J04911 1J04912 1J04913 1J04915 1J04916 1J04917 1J04918 1J04919 1J04920 1J04922 1J04924 1J04927 1J04928 1J04930 1J04938 1J04939 1J04940 1J04941 1J04942 1J04943 1J04944 1J04946 1J04947 1J04948 1J04950 1J04951 1J04953 1J04955 1J04956 1J04957 1J04958 1J04959 1J04960 1J04961 1J04962 1J04964 1J04965 1J04966 1J04967 1J04968 1J04970 1J04971 1J04973 1J04975 1J04977 1J04979 1J04980 1J04981 1J04982 1J04983 1J04984 1J04985 1J04986 1J04989 1J04990 1J05001 1J05002 1J05010 1J05012 1J05014 1J05015 1J05016 1J05017 1J05018 1J05019 1J05020 1J05023 1J05025 1J05026 1J05028 1J05031 1J05032 1J05034 1J05035 1J05036 1J05037 1J05038 1J05039 1J05041 1J05042 1J05043 1J05046 1J05047 1J05049 1J05051 1J05052 1J05059 1J05061 1J05064 1J05065 1J05073 1J05075 1J05078 1J05080 1J05082 1J05083 1J05087 1J05088 1J05089 1J05090 1J05091 1J05092 1J05095 1J05097 1J05102 1J05106 1J05107 1J05108 1J05110 1J05111 1J05113 1J05114 1J05116 1J05117 1J05118 1J05119 1J05120 1J05121 1J05123 1J05125 1J05126 1J05127 1J05128 1J05130 1J05131 1J05132 1J05133 1J05134 1J05136 1J05138 1J05139 1J05140 1J05145 1J05146 1J05148 1J05149 1J05150 1J05151 1J05152 1J05153 1J05154 1J05155 1J05156 1J05157 1J05158 1J05159 1J05160 1J05161 1J05162 1J05164 1J05165 1J05167 1J05168 1J05171 1J05172 1J05173 1J05174 1J05175 1J05177 1J05178 1J05181 1J05183 1J05185 1J05186 1J05187 1J05189 1J05190 1J05192 1J05193 1J05196 1J05197 1J05198 1J05199 1J05200 1J05201 1J05203 1J05207 1J05208 1J05209 1J05210 1J05212 1J05213 1J05214 1J05215 1J05216 1J05217 1J05218 1J05222 1J05224 1J05225 1J05227 1J05228 1J05229 1J05230 1J05231 1J05234 1J05236 1J05237 1J05238 1J05239 1J05258 1J05259 1J05260 1J05261 1J05263 1J05265 1J05266 1J05268 1J05269 1J05271 1J05272 1J05273 1J05274 1J05277 1J05278 1J05279 1J05280 1J05287 1J05288 1J05289 1J05290 1J05291 1J05292 1J05293 1J05294 1J05295 1J05299 1J05301 1J05302 1J05311 1J05312 1J05318 1J05323 1J05324 1J05325 1J05332 1J05333 1J05334 1J05335 1J05337 1J05338 1J05339 1J05340 1J05341 1J05342 1J05343 1J05344 1J05345 1J05346 1J05347 1J05348 1J05349 1J05350 1J05351 1J05352 1J05354 1J05355 1J05365 1J05366 1J05368 1J05370 1J05371 1J05372 1J05373 1J05382 1J05383 1J05384 1J05385 1J05386 1J05387 1J05388 1J05389 1J05390 1J05391 1J05392 1J05395 1J05396 1J05397 1J05398 1J05400 1J05401 1J05402 1J05404 1J05405 1J05410 1J05411 1J05412 1J05414 1J05415 1J05416 1J05418 1J05419 1J05421 1J05422 1J05423 1J05424 1J05425 1J05426 1J05427 1J05428 1J05430 1J05431 1J05432 1J05433 1J05435 1J05438 1J05439 1J05444 1J05447 1J05449 1J05450 1J05451 1J05452 1J05453 1J05454 1J05455 1J05456 1J05457 1J05458 1J05464 1J05465 1J05466 1J05467 1J05468 1J05469 1J05470 1J05471 1J05472 1J05473 1J05474 1J05475 1J05477 1J05478 1J05479 1J05480 1J05481 1J05482 1J05483 1J05485 1J05489 1J05490 1J05493 1J05495 1J05497 1J05498 1J05499 1J05500 1J05501 1J05502 1J05503 1J05505 1J05506 1J05507 1J05510 1J05511 1J05512 1J05516 1J05517 1J05518 1J05519 1J05520 1J05521 1J05523 1J05524 1J05525 1J05526 1J05528 1J05530 1J05531 1J05532 1J05533 1J05534 1J05535 1J05536 1J05537 1J05538 1J05539 1J05541 1J05542 1J05543 1J05544 1J05545 1J05546 1J05547 1J05548 1J05549 1J05550 1J05551 1J05552 1J05554 1J05555 1J05558 1J05559 1J05561 1J05562 1J05563 1J05565 1J05566 1J05568 1J05569 1J05570 1J05571 1J05572 1J05573 1J05574 1J05575 1J05576 1J05577 1J05578 1J05579 1J05580 1J05583 1J05584 1J05585 1J05586 1J05587 1J05589 1J05590 1J05591 1J05592 1J05593 1J05594 1J05595 1J05596 1J05597 1J05598 1J05599 1J05600 1J05602 1J05604 1J05605 1J05606 1J05607 1J05611 1J05613 1J05614 1J05615 1J05616 1J05617 1J05618 1J05619 1J05620 1J05622 1J05623 1J05624 1J05625 1J05626 1J05627 1J05628 1J05629 1J05630 1J05631 1J05636 1J05637 1J05638 1J05639 1J05640 1J05643 1J05645 1J05646 1J05647 1J05648 1J05649 1J05650 1J05651 1J05652 1J05653 1J05654 1J05655 1J05656 1J05657 1J05658 1J05659 1J05660 1J05661 1J05662 1J05663 1J05664 1J05665 1J05667 1J05668 1J05669 1J05670 1J05671 1J05672 1J05673 1J05674 1J05676 1J05677 1J05679 1J05680 1J05681 1J05682 1J05683 1J05684 1J05685 1J05686 1J05688 1J05689 1J05690 1J05691 1J05693 1J05696 1J05699 1J05700 1J05702 1J05703 1J05704 1J05707 1J05708 1J05709 1J05711 1J05712 1J05713 1J05715 1J05716 1J05717 1J05719 1J05720 1J05721 1J05722 1J05724 1J05725 1J05729 1J05731 1J05732 1J05733 1J05734 1J05736 1J05737 1J05738 1J05739 1J05740 1J05741 1J05743 1J05744 1J05745 1J05749 1J05750 1J05751 1J05754 1J05755 1J05757 1J05758 1J05759 1J05760 1J05761 1J05762 1J05768 1J05770 1J05771 1J05772 1J05775 1J05776 1J05780 1J05782 1J05783 1J05784 1J05785 1J05786 1J05787 1J05788 1J05789 1J05790 1J05792 1J05793 1J05794 1J05795 1J05796 1J05797 1J05798 1J05799 1J05802 1J05804 1J05805 1J05806 1J05807 1J05808 1J05809 1J05810 1J05811 1J05812 1J05813 1J05814 1J05816 1J05817 1J05818 1J05819 1J05820 1J05821 1J05822 1J05824 1J05826 1J05828 1J05829 1J05830 1J05832 1J05833 1J05835 1J05836 1J05839 1J05840 1J05841 1J05842 1J05843 1J05846 1J05848 1J05849 1J05850 1J05851 1J05852 1J05856 1J05859 1J05862 1J05863 1J05866 1J05870 1J05872 1J05873 1J05875 1J05876 1J05877 1J05879 1J05880 1J05881 1J05882 1J05883 1J05884 1J05886 1J05887 1J05888 1J05889 1J05891 1J05892 1J05893 1J05894 1J05897 1J05898 1J05899 1J05900 1J05902 1J05904 1J05905 1J05906 1J05907 1J05912 1J05913 1J05915 1J05916 1J05918 1J05919 1J05920 1J05921 1J05922 1J05923 1J05924 1J05925 1J05926 1J05927 1J05928 1J05929 1J05930 1J05931 1J05932 1J05933 1J05934 1J05935 1J05936 1J05938 1J05939 1J05942 1J05947 1J05948 1J05949 1J05950 1J05951 1J05952 1J05953 1J05955 1J05956 1J05957 1J05958 1J05959 1J05960 1J05961 1J05963 1J05964 1J05965 1J05966 1J05967 1J05969 1J05970 1J05971 1J05972 1J05974 1J05976 1J05979 1J05980 1J05981 1J05982 1J05983 1J05984 1J05985 1J05986 1J05987 1J05988 1J05989 1J05990 1J05991 1J05992 1J05993 1J05994 1J05995 1J05997 1J05998 1J06001 1J06003 1J06004 1J06005 1J06006 1J06007 1J06009 1J06010 1J06011 1J06013 1J06015 1J06016 1J06020 1J0Terumo Blood and Cell Technologies is initiating a voluntary field correction for Rika devices, catalog number 42000, due to a potential safety issue identified with an electrical component within the high-pressure and/or low-pressure control valve.
4/20/20265/6/20265/13/2026Class IINAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.Chemical contamination; presence of lead and lithium above specification
4/29/20265/4/20265/13/2026Class IIDuloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in IndiaLot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
4/29/20265/4/20265/13/2026Class IIDuloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03Lot#: PA07434, Exp. May 2026.CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
4/29/20265/4/20265/13/2026Class IIDuloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.Lot#: PA10734, Exp. Jun 2026.CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
4/22/20265/5/20265/13/2026Class IIBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.Lack of assurance of Sterility: potential product contamination
4/22/20265/5/20265/13/2026Class IIBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.Lack of assurance of Sterility: potential product contamination
4/23/20265/5/20265/13/2026Class IIEnalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.Lot #: GEH25023, Expires: 6/30/2027Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
4/21/20265/6/20265/13/2026Class IIDuloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.Lot: 241069C, Exp 05/31/2027CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
4/24/20265/5/20265/13/2026Class IIOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21. Lot: 45011002, Exp. 03/31/2027Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
4/6/20265/4/20265/13/2026Class IIDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.Lot #: 25CU02007, 25CU02008, 25CU02009Lack of Assurance of Sterility: Potential leaks from perforations in bags.
4/6/20265/4/20265/13/2026Class IIDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013Lack of Assurance of Sterility: Potential leaks from perforations in bags.
12/27/20255/7/20265/13/2026Class IITPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670Lot #: 11-4909703-0-1, Exp 12/28/2025Incorrect Product Formulation: product did not contain insulin as listed in the label.
4/28/20265/18/20265/13/2026Class ILactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.Lot #:J4P756, J4S843, Exp 5/31/2027Presence of Particulate Matter.B. Braun Medical, Inc. Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection, 1L, E7500 Due to the Presence of Particulate Matter in Solution | FDA
4/1/20264/28/20265/6/2026Class IIPhenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03120325122032719, Exp Date 04/03/2026, 120425122032734 Exp Date 04/04/2026, 120425122032735, Exp Date 04/04/2026, 120925122032781, Exp Date 04/10/2026, 010626122030010, Exp Date, 05/08/2026, 010626122030009, Exp Date 05/08/2026, 010826122030031, Exp Date 05/13/2026, 010826122030032, Exp Date 05/13/2026, 011326122030072, Exp Date 05/15/2026, 011326122030071, Exp Date 05/15/2026, 011626122030107, Exp Date 05/20/2026, 011626122030106, Exp Date 05/20/2026, 011926122030118, Exp. Date, 05/21/2026, 011926122030119, Exp Date, 05/21/2026, 012726122030171, Exp Date, 05/29/2026, 012726122030170, Exp Date 05/29/2026, 012826122030181, Exp Date 05/30/2026, 012826122030182, Exp Date 05/30/2026, 020226122030201, Exp Date 06/04/2026, 020326122030217, Exp Date 06/05/2026, 020426122030235, Exp Date 06/06/2026, 020426122030242, Exp Date 06/06/2026, 020426122030241, Exp Date 06/06/2026, 020626122030260, Exp Date 06/09/2026, 020626122030256, Exp Date 06/09/2026, 020926122030303, Exp Date 06/11/2026, 021026122030308, Exp Date, 06/12/2026, 021126122030321, Exp Date 06/13/2026, 021126122030316, Exp Date 06/13/2026, 021226122030326, Exp Date 06/16/2026, 021326122030341, Exp Date 06/17/2026, 021726122030366, Exp Date 06/19/2026, 021726122030369, Exp Date 06/19/2026, 021826122030388, Exp Date 06/20/2026, 022026122030421, Exp Date 06/24/2026, 022026122030420, Exp Date 06/24/2026, 022326122030435, Exp Date, 06/25/2026, 031026122030552, Exp Date 07/10/2026, 031026122030553, Exp Date 07/10/2026cGMP deviations.
4/1/20264/28/20265/6/2026Class IIfentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02. 120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026cGMP deviations.
4/1/20264/28/20265/6/2026Class IIfentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/06/2026, 02182202030398, Exp Date 06/20/2026.cGMP deviations.
4/1/20264/28/20265/6/2026Class IIfentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.Lot 011226204250063, Exp Date 05/14/2026cGMP deviations.
4/1/20264/28/20265/6/2026Class IIfentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.Lot 022326203650432; Exp Date 06/25/2026cGMP deviations.
4/1/20264/28/20265/6/2026Class IIKetamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026.cGMP deviations.
4/1/20264/28/20265/6/2026Class IIfentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.Lot 020226202150202, Exp Date 05/05/2026.cGMP deviations.
4/23/20264/28/20265/6/2026Class IIiVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11Lot#: 3T36B, Exp. Date October 31, 2026.Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
4/23/20264/28/20265/6/2026Class IISimilasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
4/20/20264/28/20265/6/2026Class IIOptase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.Lot#: 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26; 5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27.Lack of Assurance of Sterility
4/21/20264/24/20265/6/2026Class IISystane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027.Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
4/21/20264/24/20265/6/2026Class IIGenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
4/7/20265/8/20265/6/2026Class IIAlendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.Lot # AC2040A, Exp Date: 04/2026This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
3/20/20264/21/20264/29/2026Class IIFurosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01Lots# H03125, H03225, H03325, Exp Date: 2027/08CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
3/26/20264/17/20264/29/2026Class IIPantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10Batch # FD253967, Exp Date: 06/26/2027Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
4/2/20264/28/20264/29/2026Class IISterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
4/2/20264/28/20264/29/2026Class IIDEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.Lot # J5H166, J5H167, Exp Date: 30NOV2026.Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
4/2/20264/28/20264/29/2026Class II0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
4/2/20264/28/20264/29/2026Class IILACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
4/9/20264/24/20264/29/2026Class IIOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
4/6/20265/6/20264/29/2026Class IIClaravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.Lots#: 100067507, 100067508, Exp 07/31/2026Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
3/17/20264/14/20264/22/2026Class IIAlbuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.Lot AB6001, exp date 1/15/2027Labelling: Illegible label
3/6/20264/13/20264/22/2026Class IISemaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR Lot Number 01-27-2026@14S.5Lack of Assurance of Sterility
3/20/20264/10/20264/22/2026Class IIexchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.Lot # 20241030, Exp Date: 10/30/2026This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIexchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.Lot # 20241030, Exp Date: 10/30/2026This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIcaring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.Lot # 20241030, Exp Date: 10/30/2026This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIDiscount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092.Lot # 20241030, Exp Date: 10/30/2026This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIDiscount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.Lot # 20241030, Exp Date: 10/30/2026This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIMGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/24/20264/17/20264/22/2026Class IIMemantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61Lot # N02425, Exp Date: 05/31/2027.Failed Dissolution Specifications
3/16/20264/10/20264/22/2026Class IICinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
3/16/20264/10/20264/22/2026Class IICinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
3/16/20264/10/20264/22/2026Class IICinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
3/25/20264/13/20264/22/2026Class IIFluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1Lot# AD76252, Exp Date: 6/30/2026.Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
3/25/20264/13/20264/22/2026Class IIFluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.Lot# AD76251, Exp Date: 6/30/2026.Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
3/25/20264/13/20264/22/2026Class IIFluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.Lot# AD76250, Exp Date: 6/30/2026.Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
3/3/20264/10/20264/22/2026Class IIFHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, TexasLot #2595500, Exp.10/2/2026 Lot #2549700, Exp.6/12/2026 Lot #2638200, Exp.4/30/2027Chemical contamination: Presence of benzene
3/3/20264/10/20264/22/2026Class IIHydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027Lot# 2518800, Exp.: 4/30/2027 Lot# 2518900, Exp.: 4/1/2027Chemical contamination: Presence of benzene
3/3/20264/10/20264/22/2026Class IISLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.Lot# 2567200, Exp.8/1/26 Lot# 2691600, Exp.10/30/2027Chemical contamination: Presence of benzene
4/1/20264/14/20264/22/2026Class IIEPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1Lot Number: EA038A5, Expiration Date: 08/2026.Lack of Assurance of Sterility
3/3/20264/10/20264/22/2026Class IISLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.Lot# 2691700, Exp.10/31/2027 Lot# 2691800, Exp. 11/4/2027Chemical contamination: Presence of benzene
3/20/20264/10/20264/22/2026Class IIMGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.Lot# 20240524, Exp Date: 05/24/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIMGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.Lot# 20240730, Exp Date: 07/30/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIQC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.Lot# 20240720, Exp Date: 07/20/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIQC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.Lot # 20240524, Exp Date: 05/24/2026; Lot # 20240720, Exp Date: 07/20/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIQC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.Lot # 20240720, Exp Date: 07/20/2026, Lot # 20241030, Exp Date: 10/30/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIQC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398.Lot # 20240720, Exp Date: 07/20/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIQC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673.Lot # 20240720, Exp Date: 07/20/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIQC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.Lot # 20240720, Exp Date: 07/20/2026; Lot # 20240524, Exp Date: 05/24/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
3/20/20264/10/20264/22/2026Class IIQC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.Lot # 20240720, Exp Date: 07/20/2026.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
4/1/20264/22/20264/22/2026Class IIBlemish Spot Treatment, Glycolic & Salicylic, 0.5 fl oz [15 ml], Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027Failed Stability Specifications
4/2/20265/15/20264/22/2026Class IILidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials (NDC 63739-170-13), packaged in 10 count cartons (NDC 63739-170-24) and 25 count cartons (NDC 63739-170-27), Rx only, Distributed by: McKesson Corporation, dba Sky Packaging, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea All lots within expiryLack of Assurance of Sterility
4/2/20265/15/20264/22/2026Class IIBupivacaine Hydrochloride in 8.25 Dextrose Injection, USP, 0.75% (15 mg/2 mL) (7.5 mg/mL), Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea NDC 73293-0002-2 50 x 2 Single-dose ampules, NDC 73293-0002-1 - 2 mL ampule - Single Use Ampule 73293-0002-2 - 50 mL ampule in 1 package All lots within expiryLack of Assurance of Sterility
4/2/20265/15/20264/22/2026Class II0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1. All lots within expiryLack of Assurance of Sterility
4/8/20265/1/20264/22/2026Class IIDesmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0Lot: VM4231, Expires: 06/2027.Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
1/12/20264/8/20264/15/2026Class IIIsotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027Superpotent and Subpotent
1/12/20264/8/20264/15/2026Class IIIsotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .Superpotent and Subpotent
3/13/20264/3/20264/15/2026Class IILanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR1, Exp 12/31/2027; 4500119IR1, Exp 12/31/2027; 4500120IR1, Exp 12/31/2027; 4500121IR1, Exp 12/31/2027; 4500268IR1, Exp 1/31/2028; 4500269IR1, Exp 1/31/2028; 4500272IR1, Exp 1/31/2028; 4500314IR2, EXP 1/31/2028; 4500314RIR, EXP 1/31/2028; 4500315IR1, Exp 2/28/2028; 4500352IR1, Exp 2/28/2028; 4500353IR1, Exp 2/28/2028; 4500354IR1, Exp 2/28/2028; 4500355IR1, Exp 2/28/2028; 4500408IR1, Exp 2/28/2028; 4500409IR1, Exp 3/31/2028; 4500410IR1, Exp 3/31/2028; 4500480IR1, Exp 3/31/2028; 4500481IR1, Exp 3/31/2028; 4500545IR1, Exp 3/31/2028; 4500546IR1, Exp 3/31/2028; 4500588IR1, Exp 4/30/2028; 4500589IR1, Exp 4/30/2028; 4500635IR1, Exp 4/30/2028; 4500636IR1, Exp 4/30/2028; 4500687IR1, Exp 4/30/2028; 4500688IR1, Exp 4/30/2028; 4500758IR1, Exp 4/30/2028; 4500759IR1, Exp 5/31/2028; 4500788IR1, Exp 5/31/2028; 4500789IR1, Exp 5/31/2028; 4500819IR1, Exp 5/31/2028; 4500846IR1, Exp 5/31/2028; 4500849IR1, Exp 6/30/2028; 4500850IR1, Exp 7/31/2028; 4500907IR1, Exp 7/31/2028; 4501108IR1, Exp 7/31/2028; 4501109IR1, Exp 7/31/2028; 4501110IR1, Exp 7/31/2028; 4501111IR1, Exp 7/31/2028; 4501166IR1, Exp 7/31/2028; 4501386IR1, Exp 8/31/2028; 4501387IR1, Exp 8/31/2028;Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
3/13/20264/3/20264/15/2026Class IILanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 4401725IR1, Exp. 5/31/2026; 4401732IR1, Exp. 5/31/2026; 4401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 11/30/2026; 4401787IR1, Exp. 11/30/2026; 4401815IR1, Exp. 11/30/2026; 4401816IR1, Exp. 11/30/2026; 4401834IR1, Exp. 11/30/2026; 4401835IR1, Exp. 11/30/2026; 4401846IR1, Exp. 11/30/2026; 4401851IR1, Exp. 11/30/2026; 4500017IR1, Exp. 12/31/2026; 4500031IR1, Exp. 12/31/2026; 4500032IR1, Exp. 12/31/2026; 4500033IR1, Exp. 12/31/2026; 4500076IR1, Exp. 1/31/2027; 4500117IR1, Exp. 2/28/2027; 4500118IR1, Exp. 2/28/2027; 4500173IR1, Exp. 4/31/2027; 4500270IR1, Exp. 2/28/2027; 4500271IR1, Exp. 2/28/2027; 4500273IR1, Exp. 2/28/2027; 4500312IR1, Exp. 2/28/2027; 4500313IR1, Exp. 3/31/2027; 4500350IR1, Exp. 3/31/2027; 4500351IR1, Exp. 3/31/2027; 4500383IR1, Exp. 3/31/2027; 4500404IR1, Exp. 3/31/2027; 4500436RI1, Exp. 3/31/2027; 4500482IR1, Exp. 4/30/2027; 4500543IR1, Exp. 4/30/2027; 4500544IR1, Exp. 4/30/2027; 4500586IR1, Exp. 5/31/2027; 4500587IR1, Exp. 5/31/2027; 4500633IR1, Exp. 5/31/2027; 4500634IR1, Exp. 5/31/2027; 4500686IR1, Exp. 5/31/2027; 4500695IR1, Exp. 5/31/2027; 4500696IR1, Exp. 5/31/2027; 4500756IR1, Exp. 6/30/2027; 4500757IR1, Exp. 6/30/2027; 4500790IR1, Exp. 6/30/2027; 4500820IR1, Exp. 6/30/2027; 4500843IR1, Exp. 6/30/2027; 4500845IR1, Exp. 6/30/2027; 4500854IR1, Exp. 6/30/2027; 4500898IR1, Exp. 6/30/2027; 4500899IR1, Exp. 6/30/2027; 4500900IR1, Exp. 7/31/2027; 4500941IR1, Exp. 6/30/2027; 4500942IR1, Exp. 6/30/2027; 4500954IR1, Exp. 6/30/2027; 4500955IR1, Exp. 8/31/2027; 4500956IR1, Exp. 8/31/2027; 4500960IR1, Exp. 7/31/2027; 4501104IR1, Exp. 8/31/2027; 4501105IR1, Exp. 8/31/2027; 4501107IR1, Exp. 8/31/2027; 4501163IR1, Exp. 8/31/2027; 4501168IR1, Exp. 8/31/2027; 4501169IR1, Exp. 8/31/2027; 4501216IR1, Exp. 8/31/2027; 4501280IR1, Exp. 9/30/2027; 4501493IR1, Exp. 9/30/2027; 4501381IR1, Exp. 9/30/2027; 4501279IR1, Exp. 9/30/2027; 4501380IR1, Exp. 9/30/2027;Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
3/11/20264/3/20264/15/2026Class II0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). Batch # 6402413, Exp Date: 02/29/2028Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.Batch# 6402299, 6402300, 6402301, 6402302, 6402303, Exp Date: 01/31/2027; Batch# 6402305, 6402398, Exp Date: 02/28/2027; Batch# 6402467, Exp Date: 04/30/2027; Batch# 6402577, 6402578, Exp Date: 06/30/2027.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.Batch# 24EU10010, Exp Date: 05/31/2027.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.Batch# 6402296, Exp Date: 07/31/2026.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.Lack of Assurance of Sterility
3/11/20264/3/20264/15/2026Class II5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.Batch# 6402165, Exp Date: 05/30/2028.Lack of Assurance of Sterility
3/17/20264/8/20264/15/2026Class IIXanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91Lot# 8177156, Exp Date: 02/28/2027Failed Dissolution Specifications
3/19/20264/13/20264/15/2026Class IIClonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouchLot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.CGMP Deviations: use of an unapproved raw material
3/19/20264/13/20264/15/2026Class IIClonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouchLot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027CGMP Deviations: use of an unapproved raw material
3/19/20264/13/20264/15/2026Class IIClonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouchLot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.CGMP Deviations: use of an unapproved raw material
3/20/20264/7/20264/15/2026Class IInorepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026.Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
3/20/20264/7/20264/15/2026Class IInorepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026.Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
3/20/20264/7/20264/15/2026Class IIVancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026.Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
3/20/20264/7/20264/15/2026Class IIVancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026.Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
3/20/20264/7/20264/15/2026Class IIVancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026.Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
3/24/20264/9/20264/15/2026Class IIGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028Presence of particulate matter
3/24/20264/9/20264/15/2026Class IIGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029Presence of particulate matter
3/25/20264/7/20264/15/2026Class IIArtificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424MLack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IISterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47010 6; b) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; c) Discount drug mart, Eye Drops A.C., Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01158 0; d) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; e) Walgreens, Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17954 4; f) CAREONE, Itchy relief Eye drops, DISTRIBUTED BY: FOODHOLD U.S.A, LLC., LANDOVER, MD 20785; g) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; h) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6; i) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-598-01; j) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7Lot: a) AC24E01, Exp.: 05/31/26; b) AC24E01, Exp.: 05/31/26; c) AC24E01, Exp.: 05/31/26; d) AC24E01, Exp.: 05/31/26; e) AC24E01, Exp.: 05/31/26; f) AC24E01, Exp.: 05/31/26; g) AC24E01, Exp.: 05/31/26; h)AC24E01, Exp.: 05/31/26; i) AC24E01, Exp.: 05/31/26; j) AC24E01, Exp.: 05/31/26;Lack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IIEYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01.Lot: a) AR24D01, Exp.: 04/30/26; AR24G01, AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; b) AR24D01, Exp.: 04/30/26; AR24G01, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; c) AR24D01, Exp.: 04/30/26; AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; d) AR24G02, Exp.: 07/31/26; e) AR24G02, Exp.: 07/31/26; f) AR24G02, Exp.: 07/31/26; g) AR24M01, Exp.: 10/31/26, h) AR24G01, Exp.: 07/31/26; AR24M01, Exp.:10/31/26; I) AR24M01, Exp.:10/31/26; j) AR24D01, Exp.: 04/30/26.Lack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IIDry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05 Lot: a) LT24E01, LT24E02, LT24E03, Exp.: 05/31/26; LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; LT24M01, LT24M02, Exp.: 10/31/26; b) LT24E03, Exp.: 05/31/26; LT24F01, Exp.:06/30/26; LT24G01, Exp.:07/31/26; LT24M02, Exp.: 10/31/26; c) LT24F01, Exp.: 06/30/26; d) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; e) LT24F01, Exp.: 06/30/26; f) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; g) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; h) LT24F01, Exp.: 06/30/26; i) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; j) LT24F01, Exp.: 06/30/26; k) LT24G01, Exp.: 07/31/26; L) LT24F01, Exp.: 06/30/26; m)Lack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IIUltra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9. Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; h) SU24E01, Exp.: 5/31/26; i) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; j) SU24E03, Exp.: 5/31/26; k) SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; L) SU24K01, Exp.: 9/30/26.Lack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IISterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3 Lot: a) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; b) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; c) RG24G02, Exp.: 07/31/26; d) RG24E01, Exp.: 05/31/26; RG24G01, RG24G02; Exp.: 07/31/26; e) RG24E01, Exp.: 05/31/26; RG24G01, Exp.: 07/31/26; f) RG24E01, Exp.: 05/31/26; RG24G02; Exp.: 07/31/26; g) RG24E01, Exp.: 05/31/26; h) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; i) RG24E01, Exp.: 05/31/26; j) RG24E01, Exp.: 05/31/26; k) RG24E01, Exp.: 05/31/26; L) RG24E01, Exp.: 05/31/26; m) RG24E01, Exp.: 05/31/26; n) RG24G01, Exp.: 07/31/26; o) RG24G01, Exp.: 07/31/26; p) RG24G02, Exp.: 07/31/26; q)RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; r) RG24G02, Exp.: 07/31/26Lack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IISterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4 Lot: a) RL24D01, Exp.: 04/30/26; RL24F01, RL24F02, Exp.:06/30/26; b) RL24F01, RL24F02, Exp.:06/30/26; c) RL24F01, Exp.:06/30/26; d) RL24F02, Exp.:06/30/26; e) RL24F01, RL24F02, Exp.:06/30/26; f) RL24F01, RL24F02, Exp.:06/30/26; g) RL24F01, RL24F02, Exp.:06/30/26; h) RL24F01, Exp.:06/30/26; i) RL24F01, Exp.:06/30/26; j) RL24F02, Exp.:06/30/26; k)Lack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IISTERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles; a) Rugby LUBRICATING EYE DROPS, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1219-94; b) Walgreens, Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20300 3 Lot: a) SY24K01, SY24K02, Exp.: 09/30/26; b) SY24K01, SY24K02, Exp.: 09/30/26.Lack of Assurance of Sterility
3/3/20263/31/20264/8/2026Class IIArtificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14 Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26.Lack of Assurance of Sterility
3/19/20263/30/20264/8/2026Class IItraMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
3/18/20263/31/20264/8/2026Class IIBromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
3/27/20263/31/20264/8/2026Class IIPrazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
3/27/20263/31/20264/8/2026Class IIPrazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
3/27/20263/31/20264/8/2026Class IIPrazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
3/18/20264/13/20264/8/2026Class IMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3. Lot: AH250162, Exp 8/31/2027Product mix up: An IV bag, contained within a labeled Magnesium Sulfate in Water for Injection, 4 g/100 mL foil pouch, was identified as Tranexamic AcidAmneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) Due to a Product Mix-up with Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL | FDA
2/26/20263/24/20264/1/2026Class IILevothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44Lot 16240062A, exp date 3/2026Subpotent Drug
3/16/20263/31/20264/1/2026Class IIMeclizine Hydrochloride Tablets, USP 12.5 mg*, 50 Tablets (5 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC 60687-775-65. Lot #1024852; Exp 9/30/2026Failed tablet specifications.
3/17/20263/20/20264/1/2026Class IICUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.Lack of Assurance of Sterility
3/17/20263/27/20264/1/2026Class IIOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
3/17/20263/27/20264/1/2026Class IIOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027.Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
3/17/20263/27/20264/1/2026Class IIOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08.Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027.Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
2/4/20263/18/20263/25/2026Class IIDexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01Lot #: A240421, Exp 07/31/2026Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
3/2/20263/16/20263/25/2026Class IIChildren's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.Lot: 7261973A, 7261974A, Exp 01/31/2027Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
3/2/20265/11/20263/25/2026Class IWebcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.Lot #: 25K064362 25K064762 25K064962 25K065762 25K066062 25K079662 25K079762 25K079862 25K080862 25K080762 25K081962 25K082062 25L013962 25L015162 25K080662 25K081662 25K081762 25K081862 25L014262 25L015762 25G045062 25L014462 25L014562 25L014662 25L014762 25L014862 25L014962 25L015062 25L016162 25L028262 25L028362 25L029462 25L028462 25L028562 25L028662 25L028762 25L029562 25L028862 25L028962 25L029062 25L029662 25L029762 25L029362 25L044562 25L044062 25L044162 25L044762 25L044862 25L045262 25L055962 25L056062 25L057162 25L029162 25L029262 25L029862 25L029962 25L030062 25L056162 25L056262 25L056362 25L057262 25L057362 25L044362 25L044462 25L044962 25L045062 25L045162 25L056562 25L058262 25L056462 25L056662 25L056762 25L056862 25L056962 25L057062 25L057462 25L057562 25L057662 25L057762 25L057862 25L057962 25L058162 25M020862 25M020962 25M021162 25M021262 25M022062 25M022162 25M022262 25M027962 25M028062 25M029162 25M029262 25M021862 25M021962 25M022962 25M023062 25M023162 25M021662 25M021762 25M022662 25M022762 25M028162 25M028262 25M028362 25M028562 25M028662 25M028762 25M029062 25M029362 25M029462 25M029562 25M029662 25M029762 25M029862 25M029962 25M030062 25M030362 25M047762 25M047862 25M048362 25M048762 25M047962 25M048062 25M048162 25M048462 25M048562 25M048662 25M050262 25M050362 25M050962 25M028862 25M028962 25M030262 25M048262 25M057262 25M057362 25M057462 25M058462 25M058562 25M050462 25M051162 25M021362 25M021462 25M021562 25M022462 25M022562 25M051062 25M057162 25M058362 25M057562 25M057662 25M057762 25M057862 25M057962 25M058062 25M058162 25M058662 25M058762 25M058862 25M058962 25M059062 25M059162 25M059262 25M059362 26A020562 26A020662 26A021762 26A021862 26A020762 26A020862 26A020962 26A021962 26A022062 26A022162 26A021162 26A021062 26A022262 26A022362 26A021562 26A021662 26A022462 26A022562 26A022662 26A021262 26A021362 26A021462 26A022762 26A022962 26A022862 26A034662 26A034762 26A035662 26A035762 26A034862 26A034962 26A035062 26A035862 26A035962 26A035162 26A035262 26A036062 26A036162 26A036262 25L044262 26A035362 26A035462 26A036362 26A036462 26A035562 26A036562 26A055662 26A056862 26A056962 26A055762 26A055862 26A055962 26A057062 26A057162 26A056062 26A056162 26A057262 26A057362 26A057462 25H065362 25H065462 25H066062 25H066162 25H066262 25H066362 25H066462 25J013462 25J013562 25J014362 25J014462 25H065962 25H065762 25H065862 25H066862 25H066962 25J013162 25J013262 25J013362 25J014162 25J014262 25H065562 25H065662 25H066562 25H066662 25H066762 25J012962 25J013062 25J013762 25J013862 25J013962 25J014062 25J014862 25J014962 25J033962 25J034862 25J034062 25J034162 25J034262 25J034362 25J034462 25J034962 25J035062 25J035162 25J035262 25J035362 25J013662 25J014562 25J014662 25J014762 25J034562 25J034662 25J035462 25J035562 25J035662 25J050662 25J050762 25J050862 25J051562 25J051662 25J034762 25J035762 25J035862 25J035962 25J050362 25J050462 25J050562 25J050962 25J051062 25J051262 25J051362 25J051462 25J051762 25J051862 25J051962 25J075762 25J051162 25J052062 25J052162 25J052262 25J052362 25J064362 25J064462 25J064662 25J065262 25J065362 25J065462 25J065562 25J065662 25J065862 25J075762 25J064562 25J064762 25J064862 25J064962 25J065762 25J066262 25J066362 25K004062 25K004162 25K005262 25J065962 25J065062 25J065162 25J066062 25J066162 25K004262 25K004362 25K004462 25K004562 25K004662 25K005362 25K005462 25K005562 25K005662 25K005762 25K004762 25K004862 25K005862 25K005962 25K006062 25K004962 25K005062 25K006162 25K006262 25K006362 25K005162 25K006462 25K019662 25K020862 25K020962 25K019762 25K019862 25K021062 25K021162 25K021262 25K019962 25K020062 25K021362 25K021462 25K021562 25K020162 25K020262 25K020662 25K021662 25K021762 25K021862 25K040062 25K040162 25K040262 25K040362 25K041262 25K041362 25K041462 25K041562 25K041662 25K020662 25K040462 25K040562 25K040662 25K040762 25K040962 25K041062 25K041162 25K041762 25K041862 25K041962 25K042162 25K042262 25K040862 25K042062 25K063862 25K020562 25K020362 25K020462 25K021962 25K022062 25K063962 25K064062 25K064162 25K064262 25K064462 25K065062 25K065162 25K065262 25K065362 25K064562 25K064662 25K065462 25K065562 25K065662 25K066262 25K066162 25K064862 25K065862 25K079962 25K080962 25K081062 25K080062 25K080162 25K080262 25K080362 25K080462 25K081162 25K081262 25K081362 25K081462 25K081562 25K080562 25L014062 25L014162 25L015262 25L015362 25L015462 25L015662 25L016362 25L015962 25L016062 25L030162 25L058062 25M022362 25M028462 25L014362 25L015562 25L014362 25L016262 25L015862 25M021062 25M023262 25M022862 25M030162 25M058262Microbial Contamination of Sterile Products: Affected lots have been deemed non-sterile following discovery of a contaminant (Paenibacillus phoenicis), which may pose a potential infection risk to vulnerable groups.Cardinal Health Issues Voluntary Nationwide Recall of Webcol™ Large Alcohol Prep Pad | FDA
3/5/20263/27/20263/25/2026Class IIBrimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.Lots VJ8599, Exp Date 09/30/2026 & VL1669, Exp Date 01/31/2027Lack of Assurance of Sterility
3/9/20263/20/20263/18/2026Class IIIcosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/AprFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
10/20/20253/13/20263/11/2026Class ISILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, ChinaAll lots within expiryMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam | FDA
12/15/20253/18/20263/11/2026Class IMR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7All codes; Exp 12/31/2029Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafilStuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil | FDA
1/20/20263/2/20263/11/2026Class IIFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04Lot #: MN26222, MN34722, MN25922, Exp. Date Nov 2027; MN00523, MN00523, Exp. Date Dec 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.Lot #: MN34722, MN34722, Exp. Date Nov 2027; MN34722B, Exp. Date Aug 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIDukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1Lot #: MN31621, Exp. Date Oct 2026; MN14522, MN15522, Exp. Date Apr 2027; MN28122, MN31522, Exp. Date Sept 2027; MN04223, MN06023, Exp. Date Feb 2028; MN17223, Exp. Date May 2028; MN25123, Exp Date Aug 2028; MN33123, MN33523, Exp. Date Nov 2028.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIFirst Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.Lot #: MN12121, MN13521, Exp. Date Apr 2026; MN15221, MN16721, MN16921, MN17021, MN17021B, Exp. Date May 2026; MN18521, MN18621, MN18621B, Exp. Date Jun 2026; MN24721, MN25021, Exp. Date Aug 2026; MN01123, Exp. Date Dec 2027; MN27421, MN27721, Exp. Date Sep 2026; MN31321, MN31421, Exp. Date Oct 2026; MN34321, MN34521, MN34721, Exp. Date Nov 2026; MN02022, MN03022, Exp. Date Dec 2026; MN03522, MN04622, Exp. Date Jan 2027; MN06022, MN06122, Exp. Date Feb 2027; MN12322, MN12422, MN14422, Exp. Date Apr 2027; MN15322, Exp. May 2027; MN22022, Exp. Date Jul 2027; MN25222, MN25322, MN26422, Exp. Date Aug 2027; MN27822, Exp. Date Sep 2027; MN15322, Exp. Date Nov 2027; MN06123, Exp. Date Aug 2027; MN06423, MN06523, Exp. Date Feb 2028; MN09423, MN09523, MN09723, MN10223 Exp Date Mar 2028; MN12623, MN13323, Exp. Date Apr 2028; MN15322, MN16523, Exp. Date May 2028; MN18623, MN19323, MN19423, MN20223, Exp. Date Jun 2028; MN24323, MN24423 Exp. Date Jul 2028; MN34523, Exp. Date Nov 2028; 301424, 301524, 301624, 301724, 303124, Exp. Date Dec 2028.CGMP Deviations
1/20/20263/2/20263/11/2026Class II1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta1) Lot #: MN22222, Exp. Date Jul 2027; MN05523, Exp. Date Jan 2028; MN32023, Exp. Date Oct 2028; MN15523, Exp. Date May 2028. 2) Lots MN11422B, MN11422, Exp. Date Mar 2027; MN03823, Exp. Date Jan 2028; MN09223 Exp. Date Mar 2028; MN32123, Exp. Date Oct 2028; MN20323, Exp. Date Jun 2028; MN30822 Exp. Date Oct 2027; MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222 Exp. Date Apr 2027-Apr; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug 2028. 3) Lot #: MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222, Exp. Date Apr 2027; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug2028. 4) Lot#: MN04423, Exp. Date Jan 2028; MN10022, Exp. Date Jul 2027; MN30722, Exp. Date Oct 2027; MN03523, Exp. Date Jan 2028; MN09323, Exp. Date Mar 2028; MN20223, Exp. Date July 2028; MN32223, Exp. Date Oct 2028 5) Lots MN12122 2027-Apr, MN27523 2028-Aug & MN30922 2027-Oct.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIMax Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01Lot #: MN24523, Exp. Date July 2028; MN27123, Exp. Date Aug 2028; MN28223, Exp. Date Sep 2028.CGMP Deviations
1/20/20263/2/20263/11/2026Class IISavannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02Lot #: MN24623, Exp. Date Jul 2028; MN27023, Exp. Date Aug 2028; MN32423, Exp. Oct 2028; MN300724, Exp. Date Dec 2028.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIMedi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33.Lot #: MN15922, Exp. Date Apr 2027; MN31022, Exp. Date Oct 2027; MN27223, Exp. Date 2028-Aug.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIMed Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.Lot #: MN09322, Exp. Date Mar 2027; MN15222, Exp. Date May 2027; MN21622, Exp. Date Jul 2027; MN31822, Exp. Date Oct 2027; MN06223, MN06323, Exp. Date Feb 2028; MN12523, Exp. Date Apr 2028; MN16123, Exp. Date May 2028; MN20523, MN20623, MN20723, Exp. Date Jun 2028; MN23223, Exp. Date Jul 2028; MN31123, Exp. Date Oct 2028; MN300524, MN300624 MN302624, MN302724, MN303324, Exp. Date Dec 2028.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIBZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.Lot # MN23323, Exp. Date Jul 2028; MN31323, Exp. Date Oct 2028; MN21622, Exp. Date Jul 2027; MN13123, Exp. Date Apr 2028.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIWipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.Lot #: MN16022, Exp. Date Aug 2027; MN33922, MN31222, Exp. Date Apr 2027; MN16522, Exp. Date Oct 2027; MN17022, Exp. Date Apr 2027; MN03323, Exp. Date Jan 2028; MN34622, Exp. Date Oct 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIDynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IICleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.Lot #: MN15923, Exp. Date May 2028; MN25822, Exp. Date Aug 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIMed-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.Lot #: 52347, 52348, 52349, 52350, 52351, Exp. Date Mar 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIWP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.Lot #: MN27922, MN21722, MN21822, Exp. Date Jul 2027; MN27422, MN27522, Exp. Date Sep 2027; MN25422, Exp. Date Aug 2027; MN27922, MN27922, Exp. Date Sep 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIHand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00 Lot #: MN24922, Exp. Date Aug 2027; MN31122, Exp. Date Oct 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIGreen Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73Lot #: MN15922, Exp. Date Apr 2027; MN18223, Exp. Date May 2028; MN10123, Exp. Date Mar 2028; MN27223, Exp. Date Aug 2028; MN01023, Exp. Date Dec 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.Lot #: 53518, 53519, Exp. Date Jun 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIChildren's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00Lot #: MN12122, Exp. Date Apr 2027; MN27523, Exp. Date Aug 2028; MN30922, Exp. Date Oct 2027.CGMP Deviations
1/20/20263/2/20263/11/2026Class IIAntimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.CGMP Deviations
1/26/20263/13/20263/11/2026Class IISodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.Batch I012626R-01, Exp 02/09/2026Presence of Particulate Matter: Due to production issues
1/29/20262/27/20263/11/2026Class IIMetoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054Lot#: a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027.Failed Dissolution Specifications
1/29/20262/27/20263/11/2026Class IIMetoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.Lot#: a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.Failed Dissolution Specifications
1/29/20262/27/20263/11/2026Class IIMetoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11 Lot#: a) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .Failed Dissolution Specifications
2/13/20263/2/20263/11/2026Class IISemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, ChinaLot #: CP-030-20250711, Exp. Date Jul. 24th, 2027CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
2/13/20263/2/20263/11/2026Class IISemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
2/17/20263/3/20263/11/2026Class IIMidodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.Lot # N02640, Exp Date: 08/2027Defective container; inadequately sealed blister packaging.
2/18/20263/5/20263/11/2026Class IIFIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028.Stability Data Does Not Support Expiry Date.
2/18/20263/5/20263/11/2026Class IIMAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.Lot #: 807CP-0003, Exp. Date 07/31/2026.Stability Data Does Not Support Expiry Date.
2/18/20263/5/20263/11/2026Class IIMAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.Lot #: 795CP-0005, Exp. Date 06/30/2026Stability Data Does Not Support Expiry Date.
2/24/20263/19/20263/11/2026Class IIIsotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.Lot #: 3116110, 3116130, Exp. Date 07/2026Failed Dissolution Specifications
2/26/20263/17/20263/11/2026Class IISemaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.Lot 241113, Exp Date 11/30/2026 & Lot 250103, Exp Date 1/31/2027Lack of Assurance of Sterility
2/26/20263/17/20263/11/2026Class IISemaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06Lot 240903, exp 9/30/2026Lack of Assurance of Sterility
2/26/20263/17/20263/11/2026Class IITirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03. Lot 240709, exp 7/31/2026Lack of Assurance of Sterility
2/26/20263/17/20263/11/2026Class IITirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04. Lot 240709, exp 7/31/2026Lack of Assurance of Sterility
3/3/20263/4/20263/11/2026Class IIProduct label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.Lot #: 1TM0524003A, Exp. Date 09/2026.Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
12/31/20252/25/20263/4/2026Class IIVista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.All lotsLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
12/31/20252/25/20263/4/2026Class IIVista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.All lotsLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
12/31/20252/25/20263/4/2026Class IIVista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10. All lotsLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
12/31/20252/25/20263/4/2026Class IIVista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15. All lotsLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
12/31/20252/25/20263/4/2026Class IICHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,All lotsLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
12/31/20252/25/20263/4/2026Class IIBio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.All lotsLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
12/31/20252/25/20263/4/2026Class IIBioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.All lotsLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
2/10/20262/23/20263/4/2026Class IIAdbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
2/13/20262/23/20263/4/2026Class IIAmantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.Lot # 49261, Exp: 04/30/27Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
1/14/20262/13/20262/18/2026Class IIOxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-354-01. Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
1/26/20262/11/20262/18/2026Class IIESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.Lot#: 253000132, Exp. 06/16/2026; 253000139, 253000140, Exp. 07/21/2026; 253000150, Exp. 08/08/2026; 253000151, Exp. 08/16/2026; 253000161, 253000162, Exp. 09/12/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IIESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32. Lot#: 253000117, Exp. 02/21/2026; 253000129, Exp. 06/12/2026; 253000130, Exp. 06/16/2026; 253000154, 253000155, Exp. 08/29/2026; 253000160, Exp. 09/10/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IIESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.Lot#: 253000118, Exp. 02/21/2026; 253000145, Exp. 08/02/2026; 253000146, Exp. 06/30/2026, 253000167, Exp. 09/23/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IIESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.Lot#: 253000123, Exp. 06/02/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IIESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.Lot#: 253000124, Exp. 06/02/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IIESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.Lot#: 253000126, Exp. 06/09/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IIESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.Lot#: 253000136, Exp. 07/01/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IIESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.Lot#: 253000125, Exp. 06/09/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.Lot#: 251000143, Exp. 07/07/2026; 251000160, Exp. 08/16/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.Lot#: 251000126, Exp. 06/03/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.Lot#: 251000130, Exp. 06/02/2026; 251000137, 06/19/2026; 251000152, Exp. 08/02/2026; 251000168, Exp. 08/29/2026; 251000170, Exp. 09/03/2026Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.Lot#: 251000131, Exp. 06/16/2026; 251000136, Exp. 08/02/2026; 251000150, Exp. 08/12/2026; 251000158, Exp. 08/14/2026; 251000159, Exp. 06/16/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.Lot#: 251000122, Exp. 04/01/2026; 251000151, Exp. 08/02/2026; 251000155, Exp. 08/08/2026; 251000173, Exp. 09/05/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.Lot#: 251000125, Exp. 06/02/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.Lot#: 251000145, Exp. 07/14/2026; 251000161, Exp. 08/16/2026; 251000175, Exp. 09/08/2026. .Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.Lot#: 251000132, Exp. 06/16/2026; 251000142, Exp. 06/30/2026; 251000144, Exp. 07/14/2026; 251000146, Exp. 07/21/2026; 251000162, 251000163, Exp. 08/16/2026; 251000167, Exp. 08/22/2026; 251000177, Exp. 09/12/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.Lot#: 251000127, Exp. 06/03/2026; 251000128, Exp. 06/05/2026; 251000133, 251000134, 251000135, Exp. 06/16/2026; 251000138, 251000139, 251000140, 251000141, Exp. 06/25/2026; 251000147, 251000148, 251000149, Exp. 07/28/2026; 251000156, 251000157, Exp. 08/08/2026; 251000164, 251000165, 251000166, Exp. 08/22/2026; 251000169, Exp. 08/29/2026; 251000171, 251000172, Exp. 09/03/2026; 251000180, Exp. 09/19/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.Lot#: 251000124, Exp. 06/02/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.Lot#: 254000104, Exp. 05/27/2026Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.Lot#: 254000107, Exp. 06/30/2026; 254000111, Exp. 08/07/2026. .Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.Lot#: 256000104, Exp. 07/30/2026. .Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.Lot#: 256000105, Exp. 09/19/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.Lot#: 256000103, Exp. 07/28/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/26/20262/11/20262/18/2026Class IITestosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32.Lot#: 254000105, Exp. 05/28/2026, 254000110, Exp. 08/07/2026; 254000112, 254000113, Exp. 09/26/2026.Presence of Foreign substance - potential presence of metal particulate matter
2/5/20262/13/20262/18/2026Class IIacyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56.Lot # C274-000049124, Exp Date: 28-Feb-26.Lack of Assurance of Sterility
2/5/20262/13/20262/18/2026Class IIketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56.Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26Lack of Assurance of Sterility
2/5/20262/13/20262/18/2026Class IIthiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.Lot # C274-000047651, Exp Date: 7-Feb-26; Lot # C274-000048671, Exp Date: 30-Mar-26; Lot # C274-000048828, Exp Date: 7-Apr-26; Lot # C274-000049121, Exp Date: 19-Apr-26; Lot # C274-000049127, Exp Date: 21-Apr-26; Lot # C274-000049252, Exp Date: 26-Apr-26; Lot # C274-000049260, Exp Date: 28-Apr-26; Lot # C274-000049401, Exp Date: 3-May-26; Lot # C274-000049413, Exp Date: 5-May-26; Lot # C274-000049571, Exp Date: 10-May-26; Lot # C274-000049581, Exp Date: 12-May-26; Lot # C274-000049584, Exp Date: 13-May-26; Lot # C274-000049717, Exp Date: 17-May-26; Lot # C274-000049727, Exp Date: 18-May-26.Lack of Assurance of Sterility
2/5/20262/13/20262/18/2026Class IIvancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59.Lot # C274-000049628, Exp Date: 3-May-26.Lack of Assurance of Sterility
2/5/20262/13/20262/18/2026Class IIvancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.Lack of Assurance of Sterility
2/9/20262/23/20262/18/2026Class IICetrorelix Acetate for Injection, 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. Vial: Cetrorelix Acetate for Injection, 0.25 mg per vial, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631, Made in China, NDC: 71288-556-02. Syringe: Sterile Water for Injection, USP, 1 mL, Meitheal Pharmaceuticals, Chicago, IL 60631, Made in China, NDC: 71288-557-81.Lot Q4E0112A, Exp.: 30 Apr 2027Defective Delivery System: Missing or duplicated needles within the injection kit
1/21/20261/30/20262/11/2026Class IIBisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01. Lot # GBHL24005A, Exp Date: 09/2026cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
1/26/20262/11/20262/11/2026Class IITrazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. Batch # 6160008A, Exp Date: 12/31/2026Presence of Foreign Tablets/Capsules
1/26/20262/23/20262/11/2026Class IIESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32. Lot#: 253000127, Exp. 06/09/2026; 253000133, Exp. 06/17/2026; 253000138, Exp. 07/14/2026; 253000141, Exp. 07/21/2026; 253000144, Exp. 07/28/2026; 253000147, Exp. 08/05/2026; 253000148, Exp. 08/07/2026; 253000149, Exp. 08/08/2026; 253000152, 253000153, Exp. 08/22/2026; 253000156, Exp. 09/03/2026; 253000157, Exp. 09/04/2026; 253000159, Exp. 09/05/2026; 253000164, Exp. 09/16/2026; 253000165, Exp. 09/19/2026; 253000170, Exp. 10/03/2026.Presence of Foreign substance - potential presence of metal particulate matter
1/27/20262/11/20262/11/2026Class IIDiclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7. Lot # AD92721, Exp Date: 3/31/2027.Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
1/29/20262/23/20262/11/2026Class IIMetoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054Lot#: a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027.Failed Dissolution Specifications
12/19/20251/27/20262/4/2026Class IIINON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01.Lot#: PWXT, Exp 1/31/2027Failed Disintegration Specifications: above the time expected.
12/22/20251/23/20262/4/2026Class IISterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.Lot #: G171359, expiry: 05/31/2027Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
1/15/20261/28/20262/4/2026Class IImethylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2.Lot # LG7675, Exp. Date Nov 2026Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
12/30/20251/22/20261/28/2026Class IIIcosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07. Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
1/10/20261/21/20261/28/2026Class IIFurosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. Lot# FUB125042G; Exp. 05/13/2027Presence of Foreign Substance
1/16/20261/21/20261/28/2026Class IIThyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02. Lot #H22254-1XV; Exp. 01/31/2027Subpotent Drug
1/2/20261/15/20261/21/2026Class IILanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67. Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp 30/11/2026 ; 4400154IR1 , exp 30/11/2026 ; 4400155IR1 , exp 30/11/2026 ; 4400156IR1 , exp 30/11/2026 ; 4400373IR1 , exp 31/12/2026 ; 4400374IR1 , exp 31/12/2026 ; 4400375IR1 , exp 31/12/2026 ; 4400455IR1 , exp 31/1/2027 ; 4400456IR1 , exp 31/1/2027 ; 4400457IR1 , exp 31/1/2027 ; 4400544IR1 , exp 28/2/2027 ; 4400606IR1 , exp 28/2/2027 ; 4400607IR1 , exp 28/2/2027 ; 4400696IR1 , exp 28/2/2027 ; 4400697IR1 , exp 28/2/2027 ; 4400779IR1 , exp 28/2/2027 ; 4400780IR1 , exp 28/2/2027 ; 4400781IR1 , exp 28/2/2027 ; 4400844IR1 , exp 31/3/2027 ; 4400845IR1 , exp 31/3/2027 ; 4400849IR1 , exp 31/3/2027 ; 4400984IR1 , exp 31/3/2027 ; 4400985RIR , exp 31/3/2027 ; 4400986IR1 , exp 31/3/2027 ; 4401023IR1 , exp 31/3/2027 ;Presence of Particulate Matter.
12/31/20251/14/20261/21/2026Class IILevothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10. Lot # MHA21825, Exp Date: December 31, 2027Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
10/3/20251/14/20261/21/2026Class IITESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01.Lot #: P-22-3, Exp 06-2027Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
12/12/20251/15/20261/14/2026Class IClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887.All lots within expiry.Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.MediNatura New Mexico, Inc. Expands Voluntary Nationwide Recall of ReBoost Nasal Spray and to include ClearLife Allergy Nasal Spray Due to Microbial Contamination | FDA
12/18/20251/2/20261/14/2026Class IIDexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-01. Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026; All lots within expiry.Presence of particulate matter - Glass like particles.
12/18/20251/2/20261/14/2026Class IIDexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.Presence of particulate matter - Glass like particles.
12/16/20251/7/20261/14/2026Class IIOxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027. Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
12/16/20251/7/20261/14/2026Class IIOxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03. Lot: 0522J23493; Lot: 0522J23493, expires: 03/2027.Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
12/12/20251/15/20261/14/2026Class IReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863.All lots within expiry.Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.MediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial Contamination | FDA
12/31/20251/20/20261/14/2026Class IIRosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15. Lot #49124, Exp Date 12/31/2026Out of specification for dissolution.
12/18/20251/2/20261/14/2026Class IITri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.Lot: 25JAN033A, 25JAN033B, Expires: 02/12/2026.Presence of particulate matter - Glass like particles.
12/17/202512/30/20251/7/2026Class IIBD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29. Lot #: 5086623, Exp. Date 03/31/2028Lack of Assurance of Sterlity
12/19/202512/31/20251/7/2026Class IIWegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14.Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026Presence of Particulate Matter: Hair was found in a prefilled syringe
12/19/202512/31/20251/7/2026Class IIWegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14.Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027Presence of Particulate Matter: Hair was found in a prefilled syringe
H3127_001_RX26_DrugRecallWP_C
Page Last Updated: 07/29/2026