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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.

27 recalls

  • Class II Ongoing

    Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA…

    Reason: CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

    Boehringer Ingelheim Pharmaceuticals, Inc.

    Lots, distribution and details
    Product
    Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
    Lots / codes
    Lot 3244413; Exp. 12/31/2028
    Distribution
    OH
    Quantity
    560 bottles
    Recall started
    June 12, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0657-2026
  • 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

    METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

    Reason: Presence of Foreign Tablets/Capsules.

    A-S Medication Solutions LLC · Metformin Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot# 4260340; Exp.12/31/2025.
    Distribution
    Nationwide in U.S.
    Quantity
    411 180-count bottles
    Recall started
    February 25, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0292-2025
  • Class I Ongoing

    FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

    Reason: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

    SHOPPERS- PLAZA

    Lots, distribution and details
    Lots / codes
    Batch # 001, exp. date 09/10/2026
    Distribution
    Nationwide via internet sales
    Quantity
    172 180-count bottles
    Recall started
    December 16, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0207-2025
  • Class II Terminated

    Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand…

    Reason: Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

    Granules Pharmaceuticals Inc. · Metformin

    Lots, distribution and details
    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
    Lots / codes
    Lot #: 4911311A, Exp. Date: 11/2025
    Distribution
    Distributor in OH.
    Quantity
    6,804 bottles
    Recall started
    December 30, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0192-2025
  • Class II Terminated

    Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05

    Reason: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets

    Granules Pharmaceuticals Inc. · Gabapentin

    Lots, distribution and details
    Lots / codes
    Lot 1380040A, Exp. date July 31, 2025
    Distribution
    Nationwide in the USA
    Quantity
    11,808 500-count Bottles
    Recall started
    July 31, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0634-2024
  • Class I Ongoing

    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) b…

    Reason: MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

    SUGARMDS LLC

    Lots, distribution and details
    Product
    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.
    Lots / codes
    LOT# 22165-003, EXP 09/30/2024
    Distribution
    U.S. Nationwide and online websites.
    Quantity
    32,117
    Recall started
    November 8, 2023 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0138-2024
  • Class II Ongoing

    Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1

    Reason: CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

    Preferred Pharmaceuticals, Inc.

    Lots, distribution and details
    Lots / codes
    Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
    Distribution
    Distributed to two physician consignees located in FL.
    Quantity
    147 bottles (14,700 extended release tablets)
    Recall started
    April 28, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0385-2021
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01

    Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Nostrum Laboratories Inc · Metformin Hydrochloride

    Lots, distribution and details
    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
    Lots / codes
    Lot MET200601, 07/2022
    Distribution
    Nationwide
    Quantity
    7071 bottles
    Recall started
    January 25, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0249-2021
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01

    Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Nostrum Laboratories Inc · Metformin Hydrochloride

    Lots, distribution and details
    Lots / codes
    MET200501 07/2022
    Distribution
    Nationwide
    Quantity
    6958 Bottles
    Recall started
    January 4, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0227-2021
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

    Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Nostrum Laboratories Inc · Metformin Hydrochloride

    Lots, distribution and details
    Lots / codes
    MET100201, MET100401 EXP 05/2022
    Distribution
    Nationwide
    Quantity
    20,872 bottles
    Recall started
    October 23, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0068-2021
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

    Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Nostrum Laboratories Inc · Metformin Hydrochloride

    Lots, distribution and details
    Lots / codes
    MET200101, MET200301 EXP 05/2022
    Distribution
    Nationwide
    Quantity
    12,967 bottles
    Recall started
    October 23, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0067-2021
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs In…

    Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

    Denton Pharma, Inc. · Metformin Hydrochloride

    Lots, distribution and details
    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
    Lots / codes
    a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/2020; N107052001 6/30/2021; N107052010, N107052008, N107052004, exp 9/30/2021; c) 90 count: C107051908, exp 10/31/2020, C107052002, C107051909 exp 6/30/2021, C107052001, exp 12/31/2020, C107052004, N107052006, N107052007, N107052009, N107052011, N107052012 exp 9/30/2021; d) 120 count: C107051907, N107051904, N107051906 exp 10/31/2020 C107051910, exp 6/30/2021; C107052003, C107052005, N107052003 exp 9/30/2021
    Distribution
    Indiana – Nationwide.
    Quantity
    a) 684; b) 432; c) 3668; d) 2029 bottles
    Recall started
    October 8, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0057-2021
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30

    Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

    Denton Pharma, Inc. · Metformin Hydrochloride

    Lots, distribution and details
    Product
    Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
    Lots / codes
    N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
    Distribution
    Indiana – Nationwide.
    Quantity
    N/A
    Recall started
    October 8, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0056-2021
  • Class II Ongoing

    Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Gr…

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Granules Pharmaceuticals Inc · Metformin

    Lots, distribution and details
    Product
    Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad – 500-081, India
    Lots / codes
    a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21
    Distribution
    US Nationwide
    Quantity
    a) 476,073 bottles; b) 2,100 bottles
    Recall started
    July 3, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1386-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
    Lots / codes
    HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06-2020 HF11618A 06-2020 HF15218A 07-2020 HF15318A 07-2020 HJ01418A 09-2020 HJ01518A 09-2020 HJ01618A 09-2020 HJ01718A 09-2020 HJ04718A 09-2020 HK03218A 10-2020 HK03318A 10-2020 HK03418A 10-2020 HK03518A 10-2020 HK03618A 10-2020 HK13718A 11-2020 HK13818A 11-2020 HK13918A 11-2020 HK14018A 11-2020 HK14118A 11-2020 HK14218A 11-2020 HK14318A 11-2020 HK14418A 11-2020 HK14518A 11-2020 HM00118A 11-2020
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1393-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
    Lots / codes
    HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1354-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewate…

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11
    Lots / codes
    HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1353-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
    Lots / codes
    HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1352-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
    Lots / codes
    HF06618A 6/30/2020 HF06718A 6/30/2020
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1351-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
    Lots / codes
    HA01320A 1/31/2021 HA01420A 1/31/2021 HA06820A 1/31/2021 HB03620A 1/31/2021 HB03720A 1/31/2021 HB03820A 1/31/2021 HB03920A 1/31/2021 HB04020A 1/31/2021 HB04120A 1/31/2021 HB04220A 1/31/2021 HB04320A 2/28/2021 HB04420A 1/31/2021 HB04520A 2/28/2021 HB05020A 2/28/2021 HB05120A 2/28/2021 HB05220A 2/28/2021 HB05320A 2/28/2021 HB05420A 2/28/2021 HB05520A 2/28/2021 HB05620A 2/28/2021 HB07020A 2/28/2021 HB07120A 2/28/2021 HB07220A 2/28/2021 HB07320A 2/28/2021 HB07520A 2/28/2021 HB07620A 2/28/2021 HB07720A 2/28/2021 HB07820A 2/28/2021 HB07920A 2/28/2021 HB08020A 2/28/2021 HB08220A 2/28/2021 HF05519A 6/30/2020 HF05619A 6/30/2020 HF05719A 6/30/2020 HF05819A 6/30/2020 HF05919A 6/30/2020 HF06019A 6/30/2020 HF06119A 6/30/2020 HF06219A 6/30/2020 HF06319A 6/30/2020 HF07719A 6/30/2020 HF07819A 6/30/2020 HF07919A 6/30/2020 HF08019A 6/30/2020 HF08119A 6/30/2020 HF08219A 6/30/2020 HF08319A 6/30/2020 HF08419A 6/30/2020 HF08519A 6/30/2020 HF08619A 6/30/2020 HF10119A 6/30/2020 HF10219A 6/30/2020 HF10319A 6/30/2020 HF10419A 6/30/2020 HF10519A 6/30/2020 HF10619A 6/30/2020 HF10719A 6/30/2020 HF10819A 6/30/2020 HF10919A 6/30/2020 HF11019A 6/30/2020 HF11119A 6/30/2020 HG07219A 7/31/2020 HG07319A 7/31/2020 HG07419A 7/31/2020 HG07519A 7/31/2020 HG07619A 7/31/2020 HG07719A 7/31/2020 HG07819A 7/31/2020 HG07919A 7/31/2020 HG08019A 7/31/2020 HG08119A 7/31/2020 HH00619A 7/31/2020 HH00719A 7/31/2020 HH00819A 7/31/2020 HH00919A 7/31/2020 HH01019A 7/31/2020 HH01119A 8/31/2020 HH01219A 8/31/2020 HH01319A 8/31/2020 HH01419A 8/31/2020 HH01519A 8/31/2020 HH07319A 8/31/2020 HH07419A 8/31/2020 HH07519A 8/31/2020 HH07619A 8/31/2020 HH07719A 8/31/2020 HH07819A 8/31/2020 HH07919A 8/31/2020 HH08019A 8/31/2020 HH08119A 8/31/2020 HH08219A 8/31/2020 HH11119A 10/31/2020 HH11219A 10/31/2020 HH11319A 10/31/2020 HH11419A 10/31/2020 HH11519A 10/31/2020 HH11619A 10/31/2020 HH11719A 10/31/2020 HH11819A 10/31/2020 HH11919A 10/31/2020 HH12019A 10/31/2020 HH12119A 10/31/2020 HH12219A 10/31/2020 HH12319A 10/31/2020 HH12419A 10/31/2020 HH12519A 10/31/2020 HH12619A 10/31/2020 HH12719A 10/31/2020 HH12819A 10/31/2020 HH12919A 10/31/2020 HH13019A 10/31/2020 HL00119A 10/31/2020 HL00219A 11/30/2020 HL00319A 11/30/2020 HL00419A 11/30/2020 HL00519A 11/30/2020 HL00619A 11/30/2020 HL00719A 11/30/2020 HL00819A 11/30/2020 HL00919A 11/30/2020 HL01019A 11/30/2020
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1350-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Br…

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC · Metformin Hydrochloride

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10
    Lots / codes
    AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273A 10/31/2021 AM191274A 10/31/2021 AM191338A 11/30/2021 AM191339A 11/30/2021 AM191340A 11/30/2021 AM191341 12/31/2021 AM191342 12/31/2021 AM200109 12/31/2021 AM200110 12/31/2021 AM200111 12/31/2021
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1349-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01
    Lots / codes
    HF02318A 6/30/2020 HF02418A 6/30/2020 HF02518A 6/30/2020 HF07718A 6/30/2020 HH02118A 7/31/2020 HM04418A 12/31/2020 HM04518A 12/31/2020 HM04618A 12/31/2020 HM04718A 12/31/2020 HM05518A 12/31/2020 HM05618A 12/31/2020 HM05718A 12/31/2020 HM05818A 12/31/2020 HM05918A 12/31/2020 HM06018A 12/31/2020
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1348-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridg…

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC · Metformin Hydrochloride

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10
    Lots / codes
    AM181118AA 10/31/2020 AM181191AA 9/30/2020 AM181192AA 9/30/2020 AM181235AA 9/30/2020 AM181236AA 9/30/2020 AM181237AA 9/30/2020 AM181240AA 9/30/2020 AM181241AA 9/30/2020 AM181242AA 9/30/2020 AM181243AA 9/30/2020 AM181244AA 10/31/2020 AM181268AA 10/31/2020 AM181269AA 10/31/2020 AM181270AA 10/30/2020 AM181271AA 10/31/2020 AM181272AA 10/31/2020 AM181273AA 10/31/2020 AM181274AA 10/31/2020 AM181275AA 10/31/2020 AM181276AA 10/31/2020 AM181277AA 10/31/2020 AM181307AA 10/31/2020 AM181308AA 10/31/2020 AM181309AA 10/31/2020 AM181310AA 10/31/2020 AM181311AA 10/31/2020 AM181313AA 10/31/2020 AM181314AA 10/31/2020 AM181315AA 11/30/2020 AM181316AA 11/30/2020 AM181317AA 12/31/2020 AM181419AA 11/30/2020 AM181420AA 11/30/2020 AM181421AA 11/30/2020 AM181422AA 11/30/2020 AM181423AA 11/30/2020 AM181424AA 11/30/2020 AM181425AA 11/30/2020 AM181430BA 12/31/2020 AM181455AA 12/31/2020 AM181456AA 12/31/2020 AM181457AA 12/31/2020 AM181458AA 12/31/2020 AM181459AA 12/31/2020 AM181460AA 12/31/2020 AM181461AA 12/31/2020 AM181462AA 12/31/2020 AM181463AA 12/31/2020 AM181464AA 12/31/2020 AM181465AA 12/31/2020 AM190054AA 12/31/2020 AM190055AA 12/31/2020 AM190057AA 12/31/2020 AM190058AA 12/31/2020 AM190102AA 12/31/2020 AM190103AA 12/31/2020 AM190104AA 12/31/2020 AM190105AA 12/31/2020 AM190106AA 12/31/2020 AM190107AA 12/31/2020 AM190108AA 12/31/2020 AM190120AA 12/31/2020 AM190633AA 5/31/2021 AM190634AA 5/31/2021 AM190635AA 5/31/2021 AM190636AA 5/31/2021 AM190637AA 5/31/2021 AM190638AA 5/31/2021 AM190640AA 5/31/2021 AM190641AA 5/31/2021 AM190642AA 5/31/2021 AM190664AA 5/31/2021 AM190665AA 5/31/2021 AM190666AA 5/31/2021 AM190667AA 5/31/2021 AM190668AA 5/31/2021 AM190669AA 6/30/2021 AM190670AA 6/30/2021 AM190671AA 6/30/2021 AM190672AA 6/30/2021 AM190714AA 6/30/2021 AM190934A 8/31/2021 AM190991A 8/31/2021 AM190992A 8/31/2021 AM190993A 8/31/2021 AM190994A 8/31/2021 AM191040A 9/30/2021 AM191041A 9/30/2021 AM191083A 9/30/2021 AM191084A 9/30/2021 AM191085A 9/30/2021 AM191091A 9/30/2021 AM191092A 9/30/2021 AM191105A 9/30/2021 AM191106A 10/31/2021 AM191107A 10/31/2021 AM191109A 10/31/2021 AM191186A 10/31/2021 AM191187A 10/31/2021 AM191188A 10/31/2021 AM191189A 10/31/2021 AM191190A 10/31/2021 AM191191A 10/31/2021 AM191192A 10/31/2021 AM191193A 10/31/2021 AM191194A 10/31/2021 AM191195A 10/31/2021 AM191244A 10/31/2021 AM191245A 10/31/2021 AM191246A 10/31/2021 AM191247A 10/31/2021 AM191294A 11/30/2021 AM191295A 11/30/2021 AM191296A 11/30/2021 AM191365A 11/30/2021 AM191366A 11/30/2021 AM191367A 11/30/2021 AM191392A 11/30/2021 AM191393A 11/30/2021 AM191394A 11/30/2021 AM191395A 12/31/2021 AM200001A 12/31/2021 AM200002A 12/31/2021 AM200003A 12/31/2021 AM200004A 12/31/2021 AM200005A 12/31/2021 AM200006A 12/31/2021 AM200045A 12/31/2021 AM200046A 12/31/2021 AM200047A 12/31/2021 AM200048A 12/31/2021 AM200049A 12/31/2021 AM200050A 12/31/2021 AM200051A 12/31/2021 AM200052A 12/31/2021 AM200053A 12/31/2021 AM200081A 12/31/2021 AM200082A 12/31/2021 AM200083 12/31/2021 AM200087A 12/31/2021 AM200088A 12/31/2021 AM200089 12/31/2021 AM200090 12/31/2021 AM200091 12/31/2021 AM200100 1/31/2022 AM200101 1/31/2022 AM200102 1/31/2022 AM200138 1/31/2022 AM200139 1/31/2022 AM200140 1/31/2022 AM200141 1/31/2022 AM200142 1/31/2022 AM200143 1/31/2022 AM200144 1/31/2022 AM200193 1/31/2022 AM200194 1/31/2022 AM200195 1/31/2022 AM200196 1/31/2022 AM200197 1/31/2022 AM200198 1/31/2022 AM200199 1/31/2022 AM200200 1/31/2022 AM200202 1/31/2022 AM200203 1/31/2022 AM200204 1/31/2022 AM200205 1/31/2022 AM200206 1/31/2022 AM200207 1/31/2022 AM200208 1/31/2022 AM200209 1/31/2022 AM200210 1/31/2022 AM200211 1/31/2022 AM200284 2/28/2022 AM200285 2/28/2022 AM200287 2/28/2022 AM200288 2/28/2022 AM200289 2/28/2022 AM200290 2/28/2022 AM200291 2/28/2022 AM200292 2/28/2022
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1347-2020
  • Class II Ongoing

    amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Brid…

    Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

    Amneal Pharmaceuticals of New York, LLC · Metformin Hydrochloride

    Lots, distribution and details
    Product
    amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50
    Lots / codes
    AM180641A 6/30/2020 AM180642A 6/30/2020 AM180643A 6/30/2020 AM180644A 6/30/2020 AM180645A 6/30/2020 AM180646A 6/30/2020 AM180647A 6/30/2020 AM180880A 7/31/2020 AM180881A 7/31/2020 AM180882A 7/31/2020 AM180883A 7/31/2020 AM180884A 7/31/2020 AM180885A 7/31/2020 AM180886A 7/31/2020 AM180887A 7/31/2020 AM180888A 7/31/2020 AM180889A 7/31/2020 AM180936A 7/31/2020 AM180937A 7/31/2020 AM180938A 7/31/2020 AM180939A 7/31/2020 AM180940A 7/31/2020 AM180960A 7/31/2020 AM180961A 7/31/2020 AM180962A 7/31/2020 AM180963A 7/31/2020 AM180964A 7/31/2020 AM180965A 7/31/2020 AM180992A 7/31/2020 AM180993A 7/31/2020 AM180994A 8/31/2020 AM180995A 8/31/2020 AM180996A 8/31/2020 AM180997A 8/31/2020 AM181037A 8/31/2020 AM181038A 8/31/2020 AM181039A 8/31/2020 AM181040A 8/31/2020 AM181041A 8/31/2020 AM181079A 8/31/2020 AM181080A 8/31/2020 AM181081A 8/31/2020 AM181082A 8/31/2020 AM181083A 8/31/2020 AM181084A 8/31/2020 AM181085A 8/31/2020 AM181086A 8/31/2020 AM181087A 8/31/2020 AM181088A 8/31/2020 AM181089A 8/31/2020 AM181093A 8/31/2020 AM181094A 8/31/2020 AM181095A 8/31/2020 AM181096A 8/31/2020 AM181097A 8/31/2020 AM181098A 8/31/2020 AM181099A 8/31/2020 AM181100A 8/31/2020 AM181101A 8/31/2020 AM181102A 8/31/2020 AM181116A 8/31/2020 AM181117A 9/30/2020 AM181129A 8/31/2020 AM181130A 8/31/2020 AM181131A 8/31/2020 AM181132A 8/31/2020 AM181133A 9/30/2020 AM181134A 9/30/2020 AM181135A 9/30/2020 AM181136A 9/30/2020 AM181137A 9/30/2020 AM181138A 9/30/2020 AM181183A 9/30/2020 AM181184A 9/30/2020 AM181185A 9/30/2020 AM181186A 9/30/2020 AM181187A 9/30/2020 AM181188A 9/30/2020 AM181189A 9/30/2020 AM181190A 9/30/2020 AM181235A 9/30/2020 AM181236A 9/30/2020 AM181237A 9/30/2020 AM181238A 9/30/2020 AM181239A 9/30/2020 AM181240A 9/30/2020 AM181242A 9/30/2020 AM181243A 9/30/2020 AM181314A 10/31/2020 AM181315A 11/30/2020 AM190121B 12/31/2020 AM190122B 12/31/2020 AM190713AA 6/30/2021 AM191248A 10/31/2021 AM191249A 10/31/2021 AM200192 1/31/2022 AM200322A 2/28/2022
    Distribution
    Nationwide
    Quantity
    N/A
    Recall started
    May 29, 2020 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1345-2020

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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