Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
3,222 recalls
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Class II Ongoing
Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
- Lots / codes
- Lot Prorx051525-1, Prorx051525-2, Prorx051525-3 and Prorx051525-4
- Distribution
- TX and UT
- Quantity
- 11,119 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0117-2026
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Class II Ongoing
Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
- Lots / codes
- Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4
- Distribution
- TX and UT
- Quantity
- 8,310 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0116-2026
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Class II Ongoing
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
- Lots / codes
- Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025
- Distribution
- TX and UT
- Quantity
- 8,400 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0115-2026
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Class II Ongoing
Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
- Lots / codes
- Lot# Prorx04282025-3
- Distribution
- TX and UT
- Quantity
- 2,809 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0114-2026
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Class II Ongoing
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuV…
Reason: Presence of Particulate Matter
Lots, distribution and details
- Product
- R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50
- Lots / codes
- Lot, expiry: 10149179 , exp 10/15/2025 ; 10149503 , exp 10/13/2025 ; 10149504 , exp 10/13/2025 ; 10149657 , exp 10/16/2025 ; 10149658 , exp 10/16/2025 ; 10149659 , exp 10/15/2025 ; 10150137 , exp 10/23/2025 ; 10150138 , exp 10/23/2025 ; 10150139 , exp 10/23/2025 ; 10150140 , exp 10/23/2025 ; 10149729 , exp 10/16/2025 ; 10149730 , exp 10/16/2025 ; 10149732 , exp 10/16/2025 ; 10149733 , exp 10/16/2025 ; 10149737 , exp 10/16/2025 ; 10149738 , exp 10/16/2025 ; 10149790 , exp 10/17/2025 ; 10149787 , exp 10/16/2025 ; 10149788 , exp 10/16/2025 ; 10149791 , exp 10/17/2025 ; 10149792 , exp 10/16/2025 ; 10149800 , exp 10/16/2025 ; 10149841 , exp 10/19/2025 ; 10149833 , exp 10/19/2025 ; 10149840 , exp 10/19/2025 ; 10149842 , exp 10/20/2025 ; 10149838 , exp 10/19/2025 ; 10149839 , exp 10/19/2025 ; 10149843 , exp 10/20/2025 ; 10149968 , exp 10/20/2025 ; 10149969 , exp 10/21/2025 ; 10150007 , exp 10/22/2025 ; 10150134 , exp 10/23/2025 ; 10150253 , exp 10/26/2025 ; 10150254 , exp 10/26/2025 ; 10150135 , exp 10/23/2025 ; 10150302 , exp 10/27/2025 ; 10150303 , exp 10/28/2025 ; 10150182 , exp 10/31/2025 ; 10150183 , exp 10/23/2025 ; 10150185 , exp 10/24/2025 ; 10150184 , exp 10/23/2025 ; 10150186 , exp 10/23/2025 ; 10150187 , exp 10/23/2025 ; 10150204 , exp 10/27/2025 ; 10150357 , exp 10/29/2025 ; 10150358 , exp 10/29/2025 ; 10150361 , exp 10/29/2025 ; 10150362 , exp 10/29/2025 ; 10150525 , exp 10/30/2025 ; 10150526 , exp 10/30/2025 ; 10150527 , exp 10/30/2025 ; 10150528 , exp 10/30/2025 ; 10150532 , exp 10/30/2025 ; 10150533 , exp 10/30/2025 ; 10150534 , exp 10/30/2025 ; 10150535 , exp 10/30/2025 ; 10150537 , exp 10/30/2025 ; 10150538 , exp 10/30/2025 ; 10150550 , exp 10/31/2025 ; 10150551 , exp 10/31/2025 ; 10150596 , exp 11/3/2025 ; 10150597 , exp 11/3/2025 ; 10150598 , exp 11/3/2025 ; 10150599 , exp 11/3/2025 ; 10150616 , exp 11/3/2025 ; 10150617 , exp 11/3/2025 ; 10150619 , exp 11/3/2025 ; 10150620 , exp 11/3/2025 ; 10150631 , exp 11/3/2025 ; 10150632 , exp 11/3/2025 ; 10150633 , exp 11/3/2025 ; 10150634 , exp 11/3/2025 ; 10150613 , exp 11/3/2025 ; 10150614 , exp 11/3/2025 ; 10150677 , exp 11/3/2025 ; 10150720 , exp 11/4/2025 ; 10150650 , exp 11/5/2025 ; 10150778 , exp 11/5/2025 ; 10150779 , exp 11/5/2025 ; 10150883 , exp 11/5/2025 ; 10151024 , exp 11/5/2025 ; 10151025 , exp 11/5/2025 ; 10150884 , exp 11/6/2025 ; 10151061 , exp 11/11/2025 ; 10151069 , exp 11/11/2025 ; 10150944 , exp 11/9/2025 ; 10150945 , exp 11/9/2025 ; 10151121 , exp 11/12/2025 ; 10151129 , exp 11/13/2025 ; 10150948 , exp 11/9/2025 ; 10150949 , exp 11/9/2025 ; 10151184 , exp 11/13/2025 ; 10151195 , exp 11/13/2025 ; 10150961 , exp 11/9/2025 ; 10150980 , exp 11/10/2025 ; 10150981 , exp 11/10/2025 ; 10150984 , exp 11/10/2025 ; 10150985 , exp 11/10/2025 ; 10151013 , exp 11/10/2025 ; 10151051 , exp 11/11/2025 ; 10151052 , exp 11/11/2025 ; 10151055 , exp 11/11/2025 ; 10151056 , exp 11/11/2025 ; 10151070 , exp 11/12/2025 ; 10151071 , exp 11/11/2025 ; 10151014 , exp 11/11/2025 ; 10151072 , exp 11/12/2025 ; 10151074 , exp 11/12/2025 ; 10151075 , exp 11/12/2025 ; 10151078 , exp 11/12/2025 ; 10151079 , exp 11/12/2025 ; 10151111 , exp 11/12/2025 ; 10151112 , exp 11/12/2025 ; 10151115 , exp 11/12/2025 ; 10151116 , exp 11/12/2025 ; 10151130 , exp 11/12/2025 ; 10151131 , exp 11/13/2025 ; 10151132 , exp 11/13/2025 ; 10151134 , exp 11/13/2025 ; 10151135 , exp 11/13/2025 ; 10151138 , exp 11/13/2025 ; 10151139 , exp 11/13/2025 ; 10151173 , exp 11/17/2025 ; 10151174 , exp 11/17/2025 ; 10151177 , exp 11/13/2025 ; 10151178 , exp 11/13/2025 ; 10151196 , exp 11/14/2025 ; 10151197 , exp 11/13/2025 ; 10151199 , exp 11/14/2025 ; 10151200 , exp 11/14/2025 ; 10151203 , exp 11/14/2025 ; 10151204 , exp 11/14/2025 ; 10151418 , exp 11/19/2025 ; 10151419 , exp 11/19/2025 ; 10151423 , exp 11/19/2025 ; 10151424 , exp 11/19/2025 ; 10151442 , exp 11/19/2025 ; 10151443 , exp 11/19/2025 ; 10151447 , exp 11/19/2025 ; 10151448 , exp 11/19/2025 ; 10151462 , exp 11/19/2025 ; 10151463 , exp 11/19/2025 ; 10151464 , exp 11/19/2025 ; 10151466 , exp 11/20/2025 ; 10151468 , exp 11/19/2025 ; 10151467 , exp 11/20/2025 ; 10151470 , exp 11/24/2025 ; 10151471 , exp 11/24/2025 ; 10151475 , exp 11/24/2025 ; 10151476 , exp 11/24/2025 ; 10151505 , exp 11/23/2025 ; 10151506 , exp 11/23/2025 ; 10151509 , exp 11/23/2025 ; 10151510 , exp 11/23/2025 ; 10151523 , exp 11/24/2025 ; 10151524 , exp 11/24/2025 ; 10151525 , exp 11/23/2025 ; 10151527 , exp 11/24/2025 ; 10151528 , exp 11/24/2025 ; 10151531 , exp 11/24/2025 ; 10151532 , exp 11/24/2025 ; 10151546 , exp 11/24/2025 ; 10151547 , exp 11/24/2025 ; 10151550 , exp 11/24/2025 ; 10151551 , exp 11/24/2025 ; 10151563 , exp 11/24/2025 ; 10151564 , exp 11/24/2025 ; 10151567 , exp 11/24/2025 ; 10151568 , exp 11/24/2025 ; 10151580 , exp 11/24/2025 ; 10151581 , exp 11/24/2025 ; 10151582 , exp 11/24/2025 ; 10151584 , exp 11/25/2025 ; 10151585 , exp 11/25/2025 ; 10151588 , exp 11/25/2025 ; 10151589 , exp 11/25/2025 ; 10151600 , exp 11/25/2025 ; 10151601 , exp 11/25/2025 ; 10151604 , exp 11/25/2025 ; 10151605 , exp 11/25/2025 ; 10151705 , exp 11/25/2025 ; 10151706 , exp 11/25/2025 ; 10151707 , exp 11/25/2025 ; 10151711 , exp 11/26/2025 ; 10151727 , exp 11/26/2025 ; 10151728 , exp 11/25/2025 ; 10151729 , exp 11/25/2025 ; 10151770 , exp 11/26/2025 ; 10151771 , exp 11/27/2025 ; 10151788 , exp 11/26/2025 ; 10151789 , exp 11/26/2025 ; 10151969 , exp 12/2/2025 ; 10151979 , exp 12/1/2025 ; 10151980 , exp 12/1/2025 ; 10151970 , exp 12/2/2025 ; 10151981 , exp 12/2/2025 ; 10151982 , exp 12/1/2025 ; 10151971 , exp 12/2/2025 ; 10152008 , exp 12/2/2025 ; 10152009 , exp 12/2/2025 ; 10152010 , exp 12/3/2025 ; 10152060 , exp 12/3/2025 ; 10152061 , exp 12/9/2025 ; 10152011 , exp 12/2/2025 ; 10152121 , exp 12/4/2025 ; 10152122 , exp 12/4/2025 ; 10152012 , exp 12/3/2025 ; 10152064 , exp 12/4/2025 ; 10152123 , exp 12/4/2025 ; 10152124 , exp 12/5/2025 ; 10152178 , exp 12/7/2025 ; 10152062 , exp 12/4/2025 ; 10152175 , exp 12/7/2025 ; 10152179 , exp 12/8/2025 ; 10152180 , exp 12/8/2025 ; 10152063 , exp 12/4/2025 ; 10152176 , exp 12/7/2025 ; 10152177 , exp 12/7/2025 ; 10152323 , exp 12/9/2025 ; 10152339 , exp 12/9/2025 ; 10152374 , exp 12/11/2025 ; 10152340 , exp 12/10/2025 ; 10152341 , exp 12/10/2025 ; 10152375 , exp 12/11/2025 ; 10152371 , exp 12/10/2025 ; 10152372 , exp 12/10/2025 ; 10152376 , exp 12/11/2025 ; 10152373 , exp 12/10/2025 ; 10152393 , exp 12/11/2025 ; 10152428 , exp 12/11/2025 ; 10152394 , exp 12/11/2025 ; 10152395 , exp 12/10/2025 ; 10152429 , exp 12/12/2025 ; 10152774 , exp 12/16/2025 ; 10152775 , exp 12/16/2025 ; 10152834 , exp 12/21/2025 ; 10152835 , exp 12/21/2025 ; 10152861 , exp 12/22/2025 ;
- Distribution
- U.S. Nationwide
- Quantity
- 75,885 syringes
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0113-2026
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Class II Ongoing
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lots, distribution and details
- Lots / codes
- Lot#: 18035739, Exp. Date: 11/30/2025
- Distribution
- U.S. Nationwide.
- Quantity
- 3,750 bottles.
- Recall started
- October 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0112-2026
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Class II Ongoing
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lots, distribution and details
- Lots / codes
- Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026
- Distribution
- U.S. Nationwide.
- Quantity
- 5,882 bottles.
- Recall started
- October 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0111-2026
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Class II Ongoing
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lots, distribution and details
- Lots / codes
- Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027
- Distribution
- U.S. Nationwide.
- Quantity
- 2,418 bottles.
- Recall started
- October 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0110-2026
-
Class II Ongoing
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lots, distribution and details
- Lots / codes
- Lot#:18036713, Exp Date: 08/31/2026
- Distribution
- U.S. Nationwide.
- Quantity
- 5880 bottles.
- Recall started
- October 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0109-2026
-
Class II Ongoing
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lots, distribution and details
- Lots / codes
- Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
- Distribution
- U.S. Nationwide.
- Quantity
- 8,754 bottles.
- Recall started
- October 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0108-2026
-
Class II Ongoing
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 – count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Lots, distribution and details
- Lots / codes
- Lot#: 18036908, Exp. Date: 09/30/2026
- Distribution
- U.S. Nationwide.
- Quantity
- 6,979 bottles.
- Recall started
- October 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0107-2026
-
Class II Ongoing
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-…
Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Lots, distribution and details
- Product
- Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05
- Lots / codes
- a) NDC 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026; Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026; Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52: Lot # 3010430A, Exp Date: 11/2025, Lot # 3010613A, Exp Date: 08/2026 c) NDC 0093-4069-05: Lot # 3010406A, Exp Date: 02/2026
- Distribution
- U.S. Nationwide
- Quantity
- 107,673
- Recall started
- October 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0106-2026
-
Class II Ongoing
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Lots, distribution and details
- Lots / codes
- a) NDC 0093-4068-01: Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025; Lot # 3010439A, 3010388A, Exp Date: 01/2026; Lot # 3010526A, 3010527A, Exp Date: 03/2026; Lot # 3010591A, 07/2026; Lot # 3010343A, Exp Date: 10/2025; Lot # 3010352A, Exp Date: 11/2025; Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026; Lot # 3010629A, Exp Date: 09/2026; Lot # 3010653A, Exp Date: 01/2027; Lot # 3010654A, 3010679A, 3010702A, Exp Date: 02/2027; Lot # 3010547A, Exp Date: 04/2026 b) NDC 0093-4068-10: Lot # 3010402A Exp Date: 02/2028; Lot # 3010593A, Exp Date: 07/2026, Lot # 3010610A, Exp Date: 09/2026
- Distribution
- U.S. Nationwide
- Quantity
- 291,512 bottles
- Recall started
- October 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0105-2026
-
Class II Ongoing
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Lots, distribution and details
- Lots / codes
- a) NDC 0093-4067-01: Lot # 3010544A and 3010545A, Exp Date: 10/2025; Lot # 3010567A, Exp Date: 12/2025; Lot # 3010590A, Exp Date: 02/2026; Lot # 3010601A, 3010602A, 3010603A, Exp Date: 03/2026; Lot # 3010652A, 3010670A, 3010671A, Exp Date: 07/2026; Lot # 3010678A, 3010700A, 3010701A, Exp Date: 08/2026 b) NDC 0093-4067-10: Lot # 3010440A, Exp Date: 12/2025; Lot # 3010672A, Exp Date: 07/2026
- Distribution
- U.S. Nationwide
- Quantity
- 181,659 bottles
- Recall started
- October 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0104-2026
-
Class II Ongoing
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5×4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Lots, distribution and details
- Product
- Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5×4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
- Lots / codes
- Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
- Distribution
- Nationwide within the United States
- Quantity
- 3,410 cartons
- Recall started
- October 16, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0103-2026
-
Class II Ongoing
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10×10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Lots, distribution and details
- Lots / codes
- Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
- Distribution
- Nationwide within the United States
- Quantity
- 1,818 cartons
- Recall started
- October 16, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0102-2026
-
Class II Ongoing
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10×10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Lots, distribution and details
- Product
- Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10×10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
- Lots / codes
- Lot #: 1023526, 1023555, Expiry: 07/31/2026
- Distribution
- Nationwide within the United States
- Quantity
- 1,970 cartons
- Recall started
- October 16, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0101-2026
-
Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist.…
Reason: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
- Lots / codes
- 90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
- Distribution
- U.S. Nationwide
- Quantity
- 172,263 bottles
- Recall started
- October 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0100-2026
-
Class II Ongoing
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS…
Reason: Lack of Assurance of Sterility.
Lots, distribution and details
- Product
- HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
- Lots / codes
- Lot: F2505017, Expiry: 24-Jan-2027
- Distribution
- Distributed only to one warehouse in NJ. with no further distribution
- Quantity
- 5,518 packs (11,036 Syringes) 2 syringes/carton)
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0099-2026
-
Class II Ongoing
Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N
Reason: Marketed Without an Approved NDA/ANDA
Lots, distribution and details
- Lots / codes
- none
- Distribution
- WY and VA
- Quantity
- 3 boxes
- Recall started
- October 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0098-2026
-
Class II Ongoing
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11
Reason: Lack of Assurance of Sterility.
Lots, distribution and details
- Lots / codes
- Lot: 033A23B, Expiry: 4/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 12,778 total vials
- Recall started
- October 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0097-2026
-
Class II Ongoing
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
- Lots / codes
- Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 46,848 90-count bottles
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0096-2026
-
Class II Ongoing
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
Reason: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Lots, distribution and details
- Lots / codes
- Lot#: BE51396303, Exp. Date 2027/05
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 21,912 bottles
- Recall started
- October 1, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0095-2026
-
Class II Ongoing
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Reason: Failed Tablet/Capsule Specifications
Lots, distribution and details
- Lots / codes
- Batch # BPB124341A, Exp date: 10/2026
- Distribution
- Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
- Quantity
- 46,512/30 count bottles
- Recall started
- September 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0037-2026
-
Class II Ongoing
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Tela…
Reason: Presence of Particulate Matter: Particulate matter identified as glass
Lots, distribution and details
- Product
- Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana – 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
- Lots / codes
- Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- October 1, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0036-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 2, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.