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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.

3,222 recalls

  • Class II Ongoing

    Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah,…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Clindamycin Hydrochloride

    Lots, distribution and details
    Product
    Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01
    Lots / codes
    Lot # 17241278, exp. date Jul-26 17241297, exp. date Jul-26 17241304, exp. date Jul-26 17241315, exp. date Jul-26 17241327, exp. date Jul-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0344-2025
  • Class II Ongoing

    Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 6…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Lacosamide

    Lots, distribution and details
    Product
    Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60.
    Lots / codes
    Lot # 17241125, exp. date Jun-26 17242202, exp. date Nov-26 17242204, exp. date Dec-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0343-2025
  • Class II Ongoing

    Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuti…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Diltiazem Hydrochloride

    Lots, distribution and details
    Product
    Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01
    Lots / codes
    Lot # 17241067, exp. date May-26 17241628, exp. date Aug-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0342-2025
  • Class II Ongoing

    Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Pravastatin Sodium

    Lots, distribution and details
    Product
    Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
    Lots / codes
    Lot # 17230810, exp. date Mar-26 17230811, exp. date Mar-26 17230810, exp. date Mar-26 17232501, exp. date Nov-26 17232502, exp. date Nov-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0341-2025
  • Class II Ongoing

    Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah,…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Colesevelam Hydrochloride

    Lots, distribution and details
    Product
    Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18
    Lots / codes
    Lot # 17240669, exp. date Mar-26 17240876, exp. date Apr-26 17240883, exp. date May-26 17240909, exp. date May-26 17240914, exp. date May-26 17240927, exp. date May-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0340-2025
  • Class II Ongoing

    Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC#…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Rosuvastatin Calcium

    Lots, distribution and details
    Product
    Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30
    Lots / codes
    Lot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 17240428, exp. date Feb-26 17240778, exp. date Apr-26 17241055, exp. date May-26 17241074, exp. date Jun-26 17241075, exp. date Jun-26 17241091, exp. date Jun-26 17241100, exp. date Jun-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0339-2025
  • Class II Ongoing

    Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah,…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Prochlorperazine Maleate

    Lots, distribution and details
    Product
    Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
    Lots / codes
    Lot # 17240254, exp. date Jan-26 17240257, exp. date Jan-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0338-2025
  • Class II Ongoing

    Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC#…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Lacosamide

    Lots, distribution and details
    Product
    Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60
    Lots / codes
    Lot # 17240221, exp. date Jan-26 17240222, exp. date Jan-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0337-2025
  • Class II Ongoing

    Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 0743…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Carvedilol

    Lots, distribution and details
    Product
    Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.
    Lots / codes
    Lot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0336-2025
  • Class II Ongoing

    Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwa…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Ranolazine

    Lots, distribution and details
    Product
    Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60
    Lots / codes
    Lot # 17240040, exp. date Dec-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0335-2025
  • Class II Ongoing

    Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. ND…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Teriflunomide

    Lots, distribution and details
    Product
    Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30
    Lots / codes
    Lot # 17232462, exp. date Nov-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0334-2025
  • Class II Ongoing

    Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Solifenacin Succinate

    Lots, distribution and details
    Product
    Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
    Lots / codes
    30 count bottle: 17232395, exp. date Nov-25 17232400, exp. date Nov-25 90-count bottle: 17232395, exp. date Nov-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0333-2025
  • Class II Ongoing

    Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Saxagliptin

    Lots, distribution and details
    Product
    Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
    Lots / codes
    Lot # 17232460, exp. date Nov-25 17232460, exp. date Nov-25 17241194, exp. date Jun-26 17241194, exp. date Jun-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0332-2025
  • Class II Ongoing

    Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Nitroglycerin

    Lots, distribution and details
    Product
    Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01
    Lots / codes
    Lot # 17232361, exp. date Nov-25 17232367, exp. date Nov-25 17240037, exp. date Dec-25 17240038, exp. date Dec-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0331-2025
  • Class II Ongoing

    Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Lacosamide

    Lots, distribution and details
    Product
    Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60
    Lots / codes
    Lot # 17232533, exp. date Nov-25 17232534, exp. date Nov-25 17240606, exp. date Mar-26 17240619, exp. date Mar-26 17240911, exp. date May-26 17240912, exp. date May-26 17241121, exp. date Jun-26 17241124, exp. date Jun-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0330-2025
  • Class II Ongoing

    Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Indomethacin

    Lots, distribution and details
    Product
    Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60
    Lots / codes
    Lot # 17232323, exp. date Oct-25 17232335, exp. date Oct-25 17232323, exp. date Oct-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0329-2025
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, M…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Metformin Hydrochloride

    Lots, distribution and details
    Product
    Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.
    Lots / codes
    Lot # 17232088, exp. date Sep-25 17232093, exp. date Sep-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0328-2025
  • Class II Ongoing

    Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Fluphenazine Hydrochloride

    Lots, distribution and details
    Product
    Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01
    Lots / codes
    Lot # 17232214, exp. date Sep-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0327-2025
  • Class II Ongoing

    Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Fluphenazine Hydrochloride

    Lots, distribution and details
    Product
    Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-338-01
    Lots / codes
    Lot # 17232206, exp. date Sep-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0326-2025
  • Class II Ongoing

    Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Pravastatin Sodium

    Lots, distribution and details
    Product
    Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.
    Lots / codes
    Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0325-2025
  • Class II Ongoing

    Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, N…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Nitroglycerin

    Lots, distribution and details
    Product
    Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45.
    Lots / codes
    Lot # 17232024, exp. date Aug-25 17232071, exp. date Sep-25 17232072, exp. date Sep-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0324-2025
  • Class II Ongoing

    Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC#…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Rufinamide

    Lots, distribution and details
    Product
    Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08
    Lots / codes
    Lot # 17231643, exp. date Jul-25 17231644, exp. date Jul-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0323-2025
  • Class II Ongoing

    Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 0…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Frovatriptan Succinate

    Lots, distribution and details
    Product
    Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97
    Lots / codes
    Lot # 17231352, exp. date Jun-25 17231649, exp. date Jul-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0322-2025
  • Class II Ongoing

    Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC#…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Lacosamide

    Lots, distribution and details
    Product
    Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60.
    Lots / codes
    Lot # 17230982, exp. date Apr-25 17230986, exp. date, Apr-25 17231001, exp. date, Apr-25 17240197, exp. date Jan-26 17240198, exp. date Jan-26 17240215, exp. date Jan-26 17240846, exp. date Apr-26 17240847, exp. date Apr-26
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0321-2025
  • Class II Ongoing

    Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC…

    Reason: CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA · Gabapentin

    Lots, distribution and details
    Product
    Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.
    Lots / codes
    Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-25
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0320-2025

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 14:41. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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