Advertisement



Drug Recalls

Last updated

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.

9 recalls

  • Class II Ongoing

    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.

    Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

    Appco Pharma LLC · Prazosin Hydrochloride

    Lots, distribution and details
    Lots / codes
    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. .
    Distribution
    U.S.A. Nationwide
    Quantity
    28,157 bottles- 100's count
    Recall started
    March 27, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0421-2026
  • Class II Ongoing

    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.

    Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

    Appco Pharma LLC · Prazosin Hydrochloride

    Lots, distribution and details
    Product
    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.
    Lots / codes
    Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
    Distribution
    U.S.A. Nationwide
    Quantity
    58,896 bottles- 100's count
    Recall started
    March 27, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0420-2026
  • Class II Ongoing

    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.

    Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

    Appco Pharma LLC · Prazosin Hydrochloride

    Lots, distribution and details
    Lots / codes
    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.
    Distribution
    U.S.A. Nationwide
    Quantity
    88,008 bottles- 100's count
    Recall started
    March 27, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0419-2026
  • 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.

    Teva Pharmaceuticals USA, Inc · Prazosin Hydrochloride

    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.

    Teva Pharmaceuticals USA, Inc · Prazosin Hydrochloride

    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.

    Teva Pharmaceuticals USA, Inc · Prazosin Hydrochloride

    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

    Amerisource Health Services LLC · Prazosin Hydrochloride

    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

    Amerisource Health Services LLC · Prazosin Hydrochloride

    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

    Amerisource Health Services LLC · Prazosin Hydrochloride

    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

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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

Advertisement