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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.

11 recalls

  • Class II Ongoing

    Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590…

    Reason: Failed Dissolution Specifications

    Ascend Laboratories, LLC

    Lots, distribution and details
    Product
    Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
    Lots / codes
    Lot # 25140859; Exp. Date: Jan 2027
    Distribution
    U.S. Nationwide
    Quantity
    17,304 100-count bottles
    Recall started
    April 27, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0547-2026
  • Class II Ongoing

    Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    Lot#: a) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .
    Distribution
    Nationwide
    Quantity
    19,056 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0357-2026
  • Class II Ongoing

    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.

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    Lot#: a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.
    Distribution
    Nationwide
    Quantity
    7,448 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0356-2026
  • Class II Ongoing

    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

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    Lot#: a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027.
    Distribution
    Nationwide
    Quantity
    67,043 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0355-2026
  • Class II Ongoing

    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

    Reason: Failed Dissolution Specifications

    Teva Pharmaceuticals USA, Inc · Metoprolol Succinate

    Lots, distribution and details
    Lots / codes
    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.
    Distribution
    Nationwide
    Quantity
    18,780 bottles
    Recall started
    January 29, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0354-2026
  • Class II Ongoing

    Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceutica…

    Reason: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

    Westminster Pharmaceuticals LLC · Metoprolol Tartrate

    Lots, distribution and details
    Product
    Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
    Lots / codes
    Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26
    Distribution
    Nationwide in the USA.
    Quantity
    4,456 1000-count bottles
    Recall started
    August 6, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0582-2025
  • Class II Ongoing

    Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceutical…

    Reason: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

    Westminster Pharmaceuticals LLC · Metoprolol Tartrate

    Lots, distribution and details
    Product
    Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
    Lots / codes
    Batch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26; Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26
    Distribution
    Nationwide in the USA.
    Quantity
    16,672 1000-count bottles
    Recall started
    August 6, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0581-2025
  • Class II Ongoing

    Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, In…

    Reason: Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

    Granules Pharmaceuticals Inc. · Metoprolol Succinate

    Lots, distribution and details
    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
    Lots / codes
    Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
    Distribution
    Nationwide in the USA.
    Quantity
    27,648 100-count Bottles; 5,376 500-count Bottles
    Recall started
    June 24, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0510-2025
  • Class II Ongoing

    Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00

    Reason: Presence of Foreign Substance: metal in tablet

    Rubicon Research Private Limited · Metoprolol Tartrate

    Lots, distribution and details
    Lots / codes
    Lot 231037H1, exp 6/2027
    Distribution
    Nationwide
    Quantity
    11,664 Bottles
    Recall started
    May 6, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0517-2024
  • Class II Terminated

    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Metoprolol Succinate

    Lots, distribution and details
    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
    Lots / codes
    Batch 2447J211
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0191-2024
  • Class II Terminated

    Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

    Reason: Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

    Dr. Reddy's Laboratories, Inc. · Montelukast Sodium

    Lots, distribution and details
    Lots / codes
    Lot # C2305569, Exp. date 03/31/2026
    Distribution
    Nationwide
    Quantity
    1,656 bottles
    Recall started
    October 13, 2023 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0086-2024

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.

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