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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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

4501–4525 of 5062

  • ModerateFDA (Drugs)·D-0271-2022·2021-12-15

    Antihistamine and Decongestant Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets distributed by Rugby Laboratories due to failed dissolution specifications. Affected lot AC2103329D (Exp 1/2023) was distributed nationwide in 2,184 cartons.

    Product
    Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0276-2022·2021-12-15

    Hydrocodone Bitartrate and Acetaminophen tablets recalled for product mix-up

    Ascent Pharmaceuticals is recalling Hydrocodone Bitartrate and Acetaminophen 10 mg/325 mg tablets nationwide due to a product mix-up. The recall affects 9,744 bottles and was voluntarily initiated by the manufacturer.

    Product
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN — HYDROCODONE BITARTRATE AND ACETAMINOPHEN (HYDROCODONE BITARTRATE AND ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0274-2022·2021-12-15

    Walmart Allergy Relief D Extended-Release Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Walmart brand Allergy Relief D extended-release tablets (Lot #AC2103329B) nationwide because the tablets failed to meet dissolution specifications, which may affect medication effectiveness.

    Product
    Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0277-2022·2021-12-15

    Apollo Care VANComycin Injection Recalled for Crystallization

    Apollo Care is recalling VANComycin 1g in 0.9% Sodium Chloride injection due to crystallization that makes the product appear turbid. The affected lot was distributed in Missouri.

    Product
    VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0269-2022·2021-12-15

    OTC Allergy and Congestion Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling 5,016 cartons of Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets nationwide due to failed dissolution specifications. Affected lot is AC2103329F with expiration 1/2023.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0267-2022·2021-12-15

    Allergy and Congestion tablets recalled due to failed dissolution specifications

    Dr. Reddy's Laboratories is recalling Allergy and Congestion (Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg) Extended-Release Tablets because they failed to meet dissolution specifications. Approximately 4,896 cartons distributed nationwide are affected.

    Product
    ALLERGY AND CONGESTION — ALLERGY AND CONGESTION (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0272-2022·2021-12-15

    Fexofenadine and Pseudoephedrine allergy relief tablets recalled for failed dissolution

    Dr. Reddy's Laboratories is recalling a 12 HR Allergy & Congestion Relief product distributed nationwide because the tablets failed to meet dissolution specifications, which may affect drug effectiveness.

    Product
    12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0275-2022·2021-12-15

    Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablets because they failed to meet dissolution specifications, which may affect how the medication works in the body.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0268-2022·2021-12-15

    CVS Allergy & Congestion Relief Tablets Recalled for Failed Dissolution

    Dr. Reddy's Laboratories is recalling CVS Allergy & Congestion Relief tablets (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg extended-release) nationwide due to failed dissolution specifications.

    Product
    Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0273-2022·2021-12-15

    CVS Allergy Relief D Extended-Release Tablets Recall

    CVS Allergy Relief D extended-release tablets (Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg) are being recalled because they failed dissolution specifications, meaning the tablets may not release the medication properly.

    Product
    Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2022·2021-12-08

    Pfizer 5% Dextrose Injection Recalled for Potential Bag Leakage

    Pfizer is recalling one lot of 5% Dextrose Injection (50 mL ADD-Vantage Units) due to lack of sterility assurance; the bags have the potential to leak. This is a Class II recall affecting 765 bags distributed nationwide.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2022·2021-12-08

    Methylcobalamin Solution for Injection Recalled for Sterility Risk

    ASP Cares is recalling Methylcobalamin Solution for Injection due to lack of assurance of sterility. The recall affects one lot distributed in the United States.

    Product
    Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0262-2022·2021-12-08

    Ascorbic Acid Injection Recalled Due to Lack of Sterility Assurance

    ASP CARES is recalling Ascorbic Acid Solution for Injection (500 mg/mL, 50 mL vials) distributed in the United States because the manufacturer cannot assure the product meets sterility requirements.

    Product
    Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0286-2022·2021-12-08

    Sandoz Enoxaparin Sodium Injection Recalled Due to Temperature Excursion

    Sandoz Inc. is recalling 45,036 cartons of Enoxaparin Sodium Injection USP 40 mg/0.4 mL due to temperature abuse during shipping. The affected lot was distributed nationwide.

    Product
    Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen T
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0261-2022·2021-12-08

    Biotin Solution for Injection recalled due to lack of sterility assurance

    ASP CARES is recalling Biotin Solution for Injection (10 mg/mL, 30 mL vials) because the manufacturer cannot assure the product's sterility. The affected lot was distributed in the United States.

    Product
    Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0264-2022·2021-12-08

    Tydemy Oral Contraceptive Recalled Due to Subpotent Drug

    Lupin Pharmaceuticals has recalled Tydemy oral contraceptive tablets nationwide due to subpotency. The recall affects 4,113 cartons distributed throughout the United States.

    Product
    Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0258-2022·2021-12-01

    Diclofenac Sodium Topical Solution recalled for defective container

    Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% w/w due to a defective container. The recall affects approximately 2,664 bottles distributed nationwide.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2022·2021-12-01

    Diclofenac Sodium Topical Solution recalled for defective container

    Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% due to a defective container. The recall affects 5,400 units distributed nationwide.

    Product
    Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0256-2022·2021-12-01

    Butalbital/APAP/Caf Tablets Missing Controlled Substance Label

    Bryant Ranch Prepack is recalling Butalbital, APAP, and Caffeine 50/325/40 mg tablets because the label is missing the controlled substance classification "CIII" required by law.

    Product
    Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0257-2022·2021-12-01

    Butalbital, APAP, Caffeine Tablets Missing Schedule III Label

    Bryant Ranch Prepack is recalling Butalbital, APAP, Caffeine 50/325/40 mg tablets in multiple bottle sizes because the controlled substance classification "CIII" is missing from the label.

    Product
    Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode 083929164865; b) 20-count bottles, NDC: 71335-1767-01, barcode 083921157837; c) 30-count bottles, NDC: 71335-1767-02, barcode 083922165687, d) 60-count bottles, NDC: 71335-1767-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0263-2022·2021-12-01

    Carvedilol Tablets Recalled for Failed Impurities and Degradation Specifications

    Aurobindo Pharma USA Inc. is recalling Carvedilol 6.25 mg tablets nationwide due to failed impurities and degradation specifications. Affected containers bear Batch QG0619030-A with expiration date 11/2022.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0255-2022·2021-12-01

    Topiramate 50 mg tablets recalled due to discoloration

    Unichem Pharmaceuticals USA Inc is recalling Topiramate 50 mg tablets nationwide due to discoloration. The affected lot is ZTPM20044, expiring 09/30/2022.

    Product
    TOPIRAMATE — TOPIRAMATE (TOPIRAMATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2022·2021-11-24

    Tinactin Jock Itch Powder Spray Recall Due to Benzene Contamination

    Bayer Healthcare is recalling 592,416 cans of Tinactin (Tolnaftate 1%) Jock Itch Powder Spray distributed nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

    Product
    Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2022·2021-11-24

    LOTRIMIN AF Miconazole Nitrate Powder Spray Recalled for Benzene Contamination

    Bayer is recalling LOTRIMIN AF Deodorant Powder Spray due to potential benzene contamination from manufacturing deviations at a facility where other lots were found contaminated. The recall affects 2,817,468 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2022·2021-11-24

    Tinactin Tolnaftate Liquid Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) liquid spray due to the presence of benzene chemical contamination. The product was distributed nationwide through retail channels.

    Product
    TINACTIN — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide