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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1951–1975 of 11852

  • HighFDA (Drugs)·D-0434-2023·2023-03-15

    Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency

    B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0438-2023·2023-03-15

    NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation

    Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.

    Product
    NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0441-2023·2023-03-15

    Metformin Extended-Release Tablets Recalled for Excess NDMA Contamination

    Teva Pharmaceuticals is recalling Metformin hydrochloride Extended-Release Tablets (1000 mg) due to CGMP deviations that resulted in NDMA contamination exceeding the Acceptable Daily Intake Limit. The recall affects 12,044 bottles distributed in California.

    Product
    Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0453-2023·2023-03-08

    PrimeZEN Black 6000 Capsule Recalled for Undeclared Pharmaceutical Ingredients

    The FDA is recalling PrimeZEN Black 6000 capsules distributed nationwide because they contain undeclared sildenafil and tadalafil. The product is unapproved and was marketed without FDA authorization.

    Product
    PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0360-2023·2023-03-08

    Phenylephrine injection lacks sterility assurance; FDA recalls vials

    Nephron Sterile Compounding Center has recalled phenylephrine HCl injection vials due to lack of assurance of sterility. Patients and healthcare providers should discontinue use of the affected lots.

    Product
    Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0384-2023·2023-03-08

    Dofetilide antiarrhythmic prescription drug recalled for manufacturing deviations

    Accord Healthcare is recalling 113,571 bottles of dofetilide capsules distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection. No illnesses have been reported.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0374-2023·2023-03-08

    Atorvastatin Calcium 80 mg tablets recalled for manufacturing quality deviations

    Accord Healthcare recalls Atorvastatin Calcium 80 mg tablets due to manufacturing process deviations identified during FDA inspection. 72,376 bottles were distributed in the US, Puerto Rico, and Canada.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0416-2023·2023-03-08

    Tadalafil tablets recalled for manufacturing quality control deviations

    Accord Healthcare is recalling Tadalafil 10 mg tablets in the United States, Puerto Rico, and Canada due to manufacturing quality control deviations discovered during an FDA inspection.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0406-2023·2023-03-08

    FDA Recalls Rosuvastatin Tablets Due to Manufacturing Practice Deviations

    Accord Healthcare is recalling Rosuvastatin 20 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations. The deviations could affect product quality and safety.

    Product
    ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0429-2023·2023-03-08

    FDA Recalls Ropinirole 3mg Tablets due to CGMP Deviations

    Accord Healthcare's Ropinirole 3mg tablets are being recalled due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 14,928 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0403-2023·2023-03-08

    Phenylephrine Hydrochloride Injection recalled due to manufacturing practice deviations

    Accord Healthcare is recalling Phenylephrine Hydrochloride Injection vials due to manufacturing practice deviations discovered during an FDA inspection. Affected batches were distributed in the United States, Puerto Rico, and Canada.

    Product
    Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0396-2023·2023-03-08

    Glycopyrrolate Injection, USP recalled for manufacturing practice deviations

    Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0377-2023·2023-03-08

    FDA Recalls Accord Healthcare Buspirone 15 mg Tablets for Manufacturing Deviations

    Accord Healthcare is recalling 10,992 bottles of Buspirone Hydrochloride 15 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0425-2023·2023-03-08

    Ropinirole tablets recalled due to FDA manufacturing compliance deviations

    Accord Healthcare recalls 139,332 bottles of ropinirole 0.25 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing compliance deviations identified during FDA inspection.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0357-2023·2023-03-08

    FDA Recalls Norepinephrine Injection Due to Sterility Concerns

    Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0388-2023·2023-03-08

    Doxazosin tablets recalled due to manufacturing quality control deviations

    Accord Healthcare is recalling 75,190 bottles of Doxazosin 4 mg tablets due to manufacturing quality control deviations discovered during an FDA inspection. No illnesses have been reported.

    Product
    DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0417-2023·2023-03-08

    Tadalafil Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare recalls Tadalafil 20 mg tablets due to CGMP deviations identified during FDA inspection. Approximately 613,553 bottles distributed in the US, Puerto Rico, and Canada are affected.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0356-2023·2023-03-08

    Norepinephrine Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 443,483 bottles of Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance in the product.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0369-2023·2023-03-08

    Aripiprazole 20 mg Tablets Recalled for Manufacturing Quality Deviations

    Accord Healthcare is recalling 170,448 bottles of Aripiprazole 20 mg tablets distributed in the United States, Puerto Rico, and Canada due to manufacturing quality control (CGMP) deviations identified during FDA inspection.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0415-2023·2023-03-08

    FDA Recalls Tadalafil Tablets Due to Manufacturing Practice Deviations

    Accord Healthcare's Tadalafil 5 mg tablets are being recalled due to deviations from current good manufacturing practices identified during an FDA inspection. Approximately 1,113,264 bottles were distributed across the United States, Puerto Rico, and Canada.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0411-2023·2023-03-08

    Simvastatin 40 mg tablets recalled for manufacturing practice deviations

    Accord Healthcare is recalling 1,190,484 bottles of Simvastatin 40 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations identified during an FDA inspection.

    Product
    SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0432-2023·2023-03-08

    Carbidopa and Levodopa Tablets Recalled for Inadequate Blister Packaging Seal

    The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets due to inadequate sealing of the blister packaging. The recall affects Lot M04145 distributed nationwide.

    Product
    Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: M
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0365-2023·2023-03-08

    Aripiprazole tablets recalled due to manufacturing process deviations

    Accord Healthcare is recalling 747,464 bottles of Aripiprazole 2mg tablets due to manufacturing process deviations discovered during an FDA inspection. The affected medication was distributed in the United States, Puerto Rico, and Canada.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state