The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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4851–4875 of 5062

  • HighFDA (Drugs)·D-0812-2021·2021-09-29

    Metoprolol Tartrate Tablets Recalled for Metal Wire Contamination

    Aurobindo Pharma USA Inc. is recalling Metoprolol Tartrate 100 mg tablets due to the presence of metal wire found in at least one tablet. The FDA classified this as a Class II recall affecting 2,820 bottles distributed nationwide.

    Product
    METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0814-2021·2021-09-29

    Promethazine Syrup Plain Recall Due to Microbial Contamination

    Morton Grove Pharmaceuticals is recalling Promethazine Syrup Plain 6.25 mg/5 mL in 1-pint bottles due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0818-2021·2021-09-29

    Hydroquinone Skin Bleaching Cream Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Hydroquinone 4% Skin Bleaching Cream due to subpotency affecting the active ingredient assay and preservative assay in one product each.

    Product
    HYDROQUINONE — HYDROQUINONE (HYDROQUINONE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0813-2021·2021-09-29

    Sirolimus Tablets Recalled for Failed Impurities and Degradation Specifications

    American Health Packaging is recalling Sirolimus 1 mg tablets (Lot #1000789, expiring 10/31/2022) distributed nationwide because they failed impurities and degradation specifications.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2021·2021-09-29

    Drug Recall: Chlorzoxazone Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling 1,800 bottles of Chlorzoxazone Tablets USP 375 mg nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated on August 27, 2021.

    Product
    Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2021·2021-09-29

    Glenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2021·2021-09-29

    Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0811-2021·2021-09-29

    Chantix (Varenicline) Tablets Recalled for Impurity Above FDA Limits

    Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.

    Product
    Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0817-2021·2021-09-29

    Sodium Sulfacetamide Wash Recalled for Subpotency Issues

    Monarch PCM, LLC is recalling Sodium Sulfacetamide 10% Wash due to subpotency, meaning some bottles contain insufficient active ingredient or preservative levels.

    Product
    Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0821-2021·2021-09-29

    Glenmark Naproxen Sodium Tablets recalled for CGMP deviations

    Glenmark Pharmaceuticals is recalling 9,552 bottles of Naproxen Sodium Tablets USP 275 mg nationwide due to CGMP (current Good Manufacturing Practice) deviations identified at the manufacturing facility.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0829-2021·2021-09-29

    Zonisamide 100 mg Capsules Recalled Due to Quality Control Gaps

    Direct Rx is recalling Zonisamide 100 mg Capsules (30-count bottles, Lot #17JU2118, expiration 5/31/23) distributed in Florida due to gaps in the quality system in the Quality Control microbiology laboratory.

    Product
    Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0809-2021·2021-09-29

    Pfizer recalls Chantix tablets for N-nitroso-varenicline impurity

    Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0828-2021·2021-09-29

    Betadine Povidone-Iodine Solution Swabstick recalled for subpotent drug

    Avrio Health L.P. is recalling Betadine Solution Swabstick in single and three-count packages nationwide because the product is subpotent—meaning it contains less active ingredient than specified. Consumers should stop using affected lots and consult their healthcare provider if needed.

    Product
    BETADINE — BETADINE (POVIDONE-IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0806-2021·2021-09-29

    Entacapone Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Entacapone 200 mg tablets distributed in Colorado, Florida, Missouri, and Ohio due to failed dissolution specifications that may affect drug efficacy.

    Product
    ENTACAPONE — ENTACAPONE (ENTACAPONE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0808-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for Nitroso Impurity

    Pfizer is recalling Chantix (varenicline) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit, a manufacturing deviation.

    Product
    Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0824-2021·2021-09-29

    Chlorzoxazone 750 mg Tablets Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals is recalling Chlorzoxazone 750 mg tablets nationwide due to current good manufacturing practice (CGMP) deviations. The voluntary recall affects 4,752 bottles with five affected lot numbers.

    Product
    Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2021·2021-09-29

    Zonisamide Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2021·2021-09-29

    Chantix Varenicline Tablets Recalled for N-Nitroso Impurity

    Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0807-2021·2021-09-29

    Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0816-2021·2021-09-29

    Valproic Acid Oral Solution recalled for microbial contamination

    Morton Grove Pharmaceuticals is recalling Valproic Acid Oral Solution (250 mg/5 mL) due to potential microbial contamination in liquid sugar batches used during manufacturing.

    Product
    Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0797-2021·2021-09-22

    Hydro Pineapple Burn Max Health Supplement Recalled for Undeclared Sibutramine

    Hydro Pineapple Burn Max Health supplement sachets are being recalled because they contain undeclared sibutramine and were marketed without FDA approval. The product was distributed nationwide.

    Product
    Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0796-2021·2021-09-22

    Florance Morris ANTISEPTIC Hand Sanitizer Recalled for Methanol Contamination

    Florance Morris ANTISEPTIC Hand Sanitizer (70% ethyl alcohol) in 8.45 fl oz and 33.81 fl oz bottles is being recalled due to methanol contamination found in some lots. All lots are affected due to manufacturing under the same conditions as contaminated products.

    Product
    Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0795-2021·2021-09-22

    Florance Morris Hand Sanitizer Recalled for Methanol Contamination

    Florance Morris ANTISEPTIC Hand Sanitizer (70% ethyl alcohol) distributed nationwide is recalled due to FDA-detected methanol contamination and insufficient ethanol content. The product was distributed by Asimex International LLC in Florida.

    Product
    Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0804-2021·2021-09-22

    Spironolactone Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Greenpark Compounding Pharmacy is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL due to lack of assurance of sterility. The 15 mL bottles were distributed nationwide.

    Product
    Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0805-2021·2021-09-22

    AMINOSYN II 15% Amino Acid Injection Recalled for Particulate Matter

    ICU Medical Inc is recalling AMINOSYN II 15% An Amino Acid Injection due to the presence of particulate matter including fibers, hair, and proteinaceous material found in retained samples.

    Product
    AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
    Category
    Drug
    Distribution
    Distributed nationwide