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 Date | Classification Date | FDA Notification Date | Classification | Recalled Drug | Product Information | Recall reason | Link to FDA press release; if available |
|---|---|---|---|---|---|---|---|
| 2026-01-12 00:00:00 | 2026-04-08 00:00:00 | 2026-04-15 00:00:00 | Class II | Isotretinoin 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 07/2027 | Superpotent and Subpotent | |
| 2026-01-12 00:00:00 | 2026-04-08 00:00:00 | 2026-04-15 00:00:00 | Class II | Isotretinoin 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 | |
| 2026-03-13 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | Lanreotide 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: 69097-870-67 | Lot, 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. | |
| 2026-03-13 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | Lanreotide 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 69097-906-67 | Lot, 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. | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.45% 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: 02/29/2028 | Lack of Assurance of Sterility | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 0.9% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 5% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 5% 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 | |
| 2026-03-11 00:00:00 | 2026-04-03 00:00:00 | 2026-04-15 00:00:00 | Class II | 5% 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 | |
| 2026-03-17 00:00:00 | 2026-04-08 00:00:00 | 2026-04-15 00:00:00 | Class II | Xanax 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 58151-506-91 | Lot# 8177156, Exp Date: 02/28/2027 | Failed Dissolution Specifications | |
| 2026-03-19 00:00:00 | 2026-04-13 00:00:00 | 2026-04-15 00:00:00 | Class II | Clonidine 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 pouch | Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027. | CGMP Deviations: use of an unapproved raw material | |
| 2026-03-19 00:00:00 | 2026-04-13 00:00:00 | 2026-04-15 00:00:00 | Class II | Clonidine 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 pouch | Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027 | CGMP Deviations: use of an unapproved raw material | |
| 2026-03-19 00:00:00 | 2026-04-13 00:00:00 | 2026-04-15 00:00:00 | Class II | Clonidine 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 pouch | Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027. | CGMP Deviations: use of an unapproved raw material | |
| 2026-03-20 00:00:00 | 2026-04-07 00:00:00 | 2026-04-15 00:00:00 | Class II | norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02 | Lot: 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 | |
| 2026-03-20 00:00:00 | 2026-04-07 00:00:00 | 2026-04-15 00:00:00 | Class II | norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02 | Lot: 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 | |
| 2026-03-20 00:00:00 | 2026-04-07 00:00:00 | 2026-04-15 00:00:00 | Class II | Vancomycin 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 71266-5083-01 | Lot: 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 | |
| 2026-03-20 00:00:00 | 2026-04-07 00:00:00 | 2026-04-15 00:00:00 | Class II | Vancomycin 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 71266-5085-01 | Lot: 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 | |
| 2026-03-20 00:00:00 | 2026-04-07 00:00:00 | 2026-04-15 00:00:00 | Class II | Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01 | Lot: 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 | |
| 2026-03-24 00:00:00 | 2026-04-09 00:00:00 | 2026-04-15 00:00:00 | Class II | GE 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, 2028 | Presence of particulate matter | |
| 2026-03-24 00:00:00 | 2026-04-09 00:00:00 | 2026-04-15 00:00:00 | Class II | GE 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, 2029 | Presence of particulate matter | |
| 2026-03-25 00:00:00 | 2026-04-07 00:00:00 | 2026-04-15 00:00:00 | Class II | Artificial 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 68788-7266-0 | Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M | Lack of Assurance of Sterility | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Sterile 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 7 | Lot: 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 | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | EYE 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 | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Dry 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 | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Ultra 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 | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Sterile 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.: 07/31/26 | Lack of Assurance of Sterility | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Sterile 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 | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | STERILE 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 | |
| 2026-03-03 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Artificial 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 | |
| 2026-03-19 00:00:00 | 2026-03-30 00:00:00 | 2026-04-08 00:00:00 | Class II | traMADol 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). | |
| 2026-03-18 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Bromfenac 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. | |
| 2026-03-27 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Prazosin 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. | |
| 2026-03-27 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Prazosin 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. | |
| 2026-03-27 00:00:00 | 2026-03-31 00:00:00 | 2026-04-08 00:00:00 | Class II | Prazosin 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. | |
| 2026-03-18 00:00:00 | 2026-04-13 00:00:00 | 2026-04-08 00:00:00 | Class I | Magnesium 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 8/31/2027 | Product 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 Acid | Amneal 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 |
| 2026-02-26 00:00:00 | 2026-03-24 00:00:00 | 2026-04-01 00:00:00 | Class II | Levothyroxine 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 33342-401-44 | Lot 16240062A, exp date 3/2026 | Subpotent Drug | |
| 2026-03-16 00:00:00 | 2026-03-31 00:00:00 | 2026-04-01 00:00:00 | Class II | Meclizine 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 9/30/2026 | Failed tablet specifications. | |
| 2026-03-17 00:00:00 | 2026-03-20 00:00:00 | 2026-04-01 00:00:00 | Class II | CUROSURF (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 | |
| 2026-03-17 00:00:00 | 2026-03-27 00:00:00 | 2026-04-01 00:00:00 | Class II | Octreotide 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. | |
| 2026-03-17 00:00:00 | 2026-03-27 00:00:00 | 2026-04-01 00:00:00 | Class II | Octreotide 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. | |
| 2026-03-17 00:00:00 | 2026-03-27 00:00:00 | 2026-04-01 00:00:00 | Class II | Octreotide 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. | |
| 2026-02-04 00:00:00 | 2026-03-18 00:00:00 | 2026-03-25 00:00:00 | Class II | Dexamethasone 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: 70069-025-01 | Lot #: A240421, Exp 07/31/2026 | Failed 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. | |
| 2026-03-02 00:00:00 | 2026-03-16 00:00:00 | 2026-03-25 00:00:00 | Class II | Children'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 01/31/2027 | Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. | |
| 2026-03-02 00:00:00 | N/A | 2026-03-25 00:00:00 | Not Yet Classified | Webcol 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 25M058262 | Microbial 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 |
| 2026-03-05 00:00:00 | 2026-03-27 00:00:00 | 2026-03-25 00:00:00 | Class II | Brimonidine 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 01/31/2027 | Lack of Assurance of Sterility | |
| 2026-03-09 00:00:00 | 2026-03-20 00:00:00 | 2026-03-18 00:00:00 | Class II | Icosapent 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: 70710-1592-7 | Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. | |
| 2025-10-20 00:00:00 | 2026-03-13 00:00:00 | 2026-03-11 00:00:00 | Class I | SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China | All lots within expiry | Marketed 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 |
| 2025-12-15 00:00:00 | 2026-03-18 00:00:00 | 2026-03-11 00:00:00 | Class I | MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 | All codes; Exp 12/31/2029 | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil | StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil | FDA |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04 | Lot #: MN26222, MN34722, MN25922, Exp. Date Nov 2027; MN00523, MN00523, Exp. Date Dec 2027. | CGMP Deviations | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | First 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1 | Lot #: 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | First 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | 1) 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 Atlanta | 1) 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01 | Lot #: MN24523, Exp. Date July 2028; MN27123, Exp. Date Aug 2028; MN28223, Exp. Date Sep 2028. | CGMP Deviations | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02 | Lot #: MN24623, Exp. Date Jul 2028; MN27023, Exp. Date Aug 2028; MN32423, Exp. Oct 2028; MN300724, Exp. Date Dec 2028. | CGMP Deviations | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Medi-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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Med 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | BZK 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Wipes 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Dynarex 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 67777-244-02 | Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027. | CGMP Deviations | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Cleansing 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Med-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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | WP 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Hand 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73 | Lot #: 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01 | Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027. | CGMP Deviations | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Dynarex, 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 | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Children'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 0924-7130-00 | Lot #: MN12122, Exp. Date Apr 2027; MN27523, Exp. Date Aug 2028; MN30922, Exp. Date Oct 2027. | CGMP Deviations | |
| 2026-01-20 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Antimicrobial 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 | |
| 2026-01-26 00:00:00 | 2026-03-13 00:00:00 | 2026-03-11 00:00:00 | Class II | Sodium 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 02/09/2026 | Presence of Particulate Matter: Due to production issues | |
| 2026-01-29 00:00:00 | 2026-02-27 00:00:00 | 2026-03-11 00:00:00 | Class II | Metoprolol 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 07054 | Lot#: a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027. | Failed Dissolution Specifications | |
| 2026-01-29 00:00:00 | 2026-02-27 00:00:00 | 2026-03-11 00:00:00 | Class II | Metoprolol 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 | |
| 2026-01-29 00:00:00 | 2026-02-27 00:00:00 | 2026-03-11 00:00:00 | Class II | Metoprolol 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 | |
| 2026-02-13 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Semaglutide, 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, China | Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027 | CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution | |
| 2026-02-13 00:00:00 | 2026-03-02 00:00:00 | 2026-03-11 00:00:00 | Class II | Semaglutide, 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 | |
| 2026-02-17 00:00:00 | 2026-03-03 00:00:00 | 2026-03-11 00:00:00 | Class II | Midodrine 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: 08/2027 | Defective container; inadequately sealed blister packaging. | |
| 2026-02-18 00:00:00 | 2026-03-05 00:00:00 | 2026-03-11 00:00:00 | Class II | FIVE-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. | |
| 2026-02-18 00:00:00 | 2026-03-05 00:00:00 | 2026-03-11 00:00:00 | Class II | MAXIMUM, 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. | |
| 2026-02-18 00:00:00 | 2026-03-05 00:00:00 | 2026-03-11 00:00:00 | Class II | MAXIMUM, 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 06/30/2026 | Stability Data Does Not Support Expiry Date. | |
| 2026-02-24 00:00:00 | 2026-03-19 00:00:00 | 2026-03-11 00:00:00 | Class II | Isotretinoin 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 07/2026 | Failed Dissolution Specifications | |
| 2026-02-26 00:00:00 | 2026-03-17 00:00:00 | 2026-03-11 00:00:00 | Class II | Semaglutide 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 1/31/2027 | Lack of Assurance of Sterility | |
| 2026-02-26 00:00:00 | 2026-03-17 00:00:00 | 2026-03-11 00:00:00 | Class II | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06 | Lot 240903, exp 9/30/2026 | Lack of Assurance of Sterility | |
| 2026-02-26 00:00:00 | 2026-03-17 00:00:00 | 2026-03-11 00:00:00 | Class II | Tirzepatide 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 7/31/2026 | Lack of Assurance of Sterility | |
| 2026-02-26 00:00:00 | 2026-03-17 00:00:00 | 2026-03-11 00:00:00 | Class II | Tirzepatide 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 7/31/2026 | Lack of Assurance of Sterility | |
| 2026-03-03 00:00:00 | 2026-03-04 00:00:00 | 2026-03-11 00:00:00 | Class II | Product 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 | |
| 2025-12-31 00:00:00 | 2026-02-25 00:00:00 | 2026-03-04 00:00:00 | Class II | Vista 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 lots | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | |
| 2025-12-31 00:00:00 | 2026-02-25 00:00:00 | 2026-03-04 00:00:00 | Class II | Vista 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 lots | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | |
| 2025-12-31 00:00:00 | 2026-02-25 00:00:00 | 2026-03-04 00:00:00 | Class II | Vista 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 lots | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | |
| 2025-12-31 00:00:00 | 2026-02-25 00:00:00 | 2026-03-04 00:00:00 | Class II | Vista 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 lots | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | |
| 2025-12-31 00:00:00 | 2026-02-25 00:00:00 | 2026-03-04 00:00:00 | Class II | CHNaO 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 lots | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | |
| 2025-12-31 00:00:00 | 2026-02-25 00:00:00 | 2026-03-04 00:00:00 | Class II | Bio 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 lots | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | |
| 2025-12-31 00:00:00 | 2026-02-25 00:00:00 | 2026-03-04 00:00:00 | Class II | BioGlo 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 lots | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | |
| 2026-02-10 00:00:00 | 2026-02-23 00:00:00 | 2026-03-04 00:00:00 | Class II | Adbry, (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. | |
| 2026-02-13 00:00:00 | 2026-02-23 00:00:00 | 2026-03-04 00:00:00 | Class II | Amantadine 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: 04/30/27 | Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. | |
| 2026-01-14 00:00:00 | 2026-02-13 00:00:00 | 2026-02-18 00:00:00 | Class II | Oxycodone 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 08/31/2027 | Defective 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. | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL,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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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. 09/03/2026 | Presence of Foreign substance - potential presence of metal particulate matter | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone, 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01. | Lot#: 254000104, Exp. 05/27/2026 | Presence of Foreign substance - potential presence of metal particulate matter | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone 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 | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-18 00:00:00 | Class II | Testosterone 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 | |
| 2026-02-05 00:00:00 | 2026-02-13 00:00:00 | 2026-02-18 00:00:00 | Class II | acyclovir 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 | |
| 2026-02-05 00:00:00 | 2026-02-13 00:00:00 | 2026-02-18 00:00:00 | Class II | ketamine 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-26 | Lack of Assurance of Sterility | |
| 2026-02-05 00:00:00 | 2026-02-13 00:00:00 | 2026-02-18 00:00:00 | Class II | thiamine 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 | |
| 2026-02-05 00:00:00 | 2026-02-13 00:00:00 | 2026-02-18 00:00:00 | Class II | vancomycin 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 | |
| 2026-02-05 00:00:00 | 2026-02-13 00:00:00 | 2026-02-18 00:00:00 | Class II | vancomycin 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 | |
| 2026-02-09 00:00:00 | 2026-02-23 00:00:00 | 2026-02-18 00:00:00 | Class II | Cetrorelix 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 2027 | Defective Delivery System: Missing or duplicated needles within the injection kit | |
| 2026-01-21 00:00:00 | 2026-01-30 00:00:00 | 2026-02-11 00:00:00 | Class II | Bisoprolol 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: 09/2026 | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. | |
| 2026-01-26 00:00:00 | 2026-02-11 00:00:00 | 2026-02-11 00:00:00 | Class II | Trazodone 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: 12/31/2026 | Presence of Foreign Tablets/Capsules | |
| 2026-01-26 00:00:00 | 2026-02-23 00:00:00 | 2026-02-11 00:00:00 | Class II | ESTRADIOL, 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 | |
| 2026-01-27 00:00:00 | 2026-02-11 00:00:00 | 2026-02-11 00:00:00 | Class II | Diclofenac 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%. | |
| 2026-01-29 00:00:00 | 2026-02-23 00:00:00 | 2026-02-11 00:00:00 | Class II | Metoprolol 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 07054 | Lot#: 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 | |
| 2025-12-19 00:00:00 | 2026-01-27 00:00:00 | 2026-02-04 00:00:00 | Class II | INON 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 1/31/2027 | Failed Disintegration Specifications: above the time expected. | |
| 2025-12-22 00:00:00 | 2026-01-23 00:00:00 | 2026-02-04 00:00:00 | Class II | Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. | Lot #: G171359, expiry: 05/31/2027 | Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution | |
| 2026-01-15 00:00:00 | 2026-01-28 00:00:00 | 2026-02-04 00:00:00 | Class II | methylprednisolone 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 2026 | Labeling: 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. | |
| 2025-12-30 00:00:00 | 2026-01-22 00:00:00 | 2026-01-28 00:00:00 | Class II | Icosapent 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 4/30/2027 | Subpotent 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. | |
| 2026-01-10 00:00:00 | 2026-01-21 00:00:00 | 2026-01-28 00:00:00 | Class II | Furosemide 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. 05/13/2027 | Presence of Foreign Substance | |
| 2026-01-16 00:00:00 | 2026-01-21 00:00:00 | 2026-01-28 00:00:00 | Class II | Thyroid, 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. 01/31/2027 | Subpotent Drug | |
| 2026-01-02 00:00:00 | 2026-01-15 00:00:00 | 2026-01-21 00:00:00 | Class II | Lanreotide 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. | |
| 2025-12-31 00:00:00 | 2026-01-14 00:00:00 | 2026-01-21 00:00:00 | Class II | Levothyroxine 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, 2027 | Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. | |
| 2025-10-03 00:00:00 | 2026-01-14 00:00:00 | 2026-01-21 00:00:00 | Class II | TESTO-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 06-2027 | Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. | |
| 2025-12-12 00:00:00 | 2026-01-15 00:00:00 | 2026-01-14 00:00:00 | Class I | ClearLife 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 |
| 2025-12-18 00:00:00 | 2026-01-02 00:00:00 | 2026-01-14 00:00:00 | Class II | Dexamethasone 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. | |
| 2025-12-18 00:00:00 | 2026-01-02 00:00:00 | 2026-01-14 00:00:00 | Class II | Dexamethasone 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. | |
| 2025-12-16 00:00:00 | 2026-01-07 00:00:00 | 2026-01-14 00:00:00 | Class II | Oxycodone 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. | |
| 2025-12-16 00:00:00 | 2026-01-07 00:00:00 | 2026-01-14 00:00:00 | Class II | Oxycodone 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. | |
| 2025-12-12 00:00:00 | 2026-01-15 00:00:00 | 2026-01-14 00:00:00 | Class I | ReBoost 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 |
| 2025-12-31 00:00:00 | 2026-01-20 00:00:00 | 2026-01-14 00:00:00 | Class II | Rosuvastatin 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 12/31/2026 | Out of specification for dissolution. | |
| 2025-12-18 00:00:00 | 2026-01-02 00:00:00 | 2026-01-14 00:00:00 | Class II | Tri-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. | |
| 2025-12-17 00:00:00 | 2025-12-30 00:00:00 | 2026-01-07 00:00:00 | Class II | BD 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 03/31/2028 | Lack of Assurance of Sterlity | |
| 2025-12-19 00:00:00 | 2025-12-31 00:00:00 | 2026-01-07 00:00:00 | Class II | Wegovy (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 10/31/2026 | Presence of Particulate Matter: Hair was found in a prefilled syringe | |
| 2025-12-19 00:00:00 | 2025-12-31 00:00:00 | 2026-01-07 00:00:00 | Class II | Wegovy (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 3/31/2027 | Presence of Particulate Matter: Hair was found in a prefilled syringe |
Page Last Updated: 03/24/2026