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.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of Ind…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
- Lots / codes
- Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart
- 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-0347-2025
-
Class II Ongoing
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Naproxen Sodium Tablets, USP, 550mg, 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# 68462-179-01
- Lots / codes
- Lot # 17231956, exp. date Aug-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-0346-2025
-
Class II Ongoing
Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured fo…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
- Lots / codes
- 30-Count Bottle Lots: 17241788, exp. date Sep-26 17241821, exp. date Sep-26 17241822, exp. date Sep-26 90-Count Bottle Lot: 17241822, exp. date Sept 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-0345-2025
-
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 3, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.