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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

1976–2000 of 11819

  • HighFDA (Drugs)·D-0444-2023·2023-03-15

    FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

    Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

    Product
    Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0424-2023·2023-03-08

    Pravastatin Sodium 80 mg tablets recalled for manufacturing deviations

    Accord Healthcare is recalling Pravastatin Sodium 80 mg tablets due to manufacturing process deviations discovered during an FDA inspection. The recall affects approximately 1,970 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0393-2023·2023-03-08

    Accord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations

    Accord Healthcare is recalling Glimepiride 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. The recall affects 469,944 bottles.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    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-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-0359-2023·2023-03-08

    Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials distributed nationwide.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile 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 69374-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0372-2023·2023-03-08

    Atorvastatin Calcium tablets recalled due to manufacturing practice deviations

    Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were distributed in the United States, 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-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-0422-2023·2023-03-08

    Pravastatin Sodium tablets recalled for manufacturing practice violations

    Accord Healthcare is recalling Pravastatin Sodium 20 mg tablets following an FDA inspection that identified manufacturing practice deviations. Approximately 32,688 bottles were distributed in the United States, Puerto Rico, and Canada.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0361-2023·2023-03-08

    Phenylephrine HCl Injection Recalled for Sterility Assurance Deficiency

    Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.

    Product
    Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 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 69374-301-10.
    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-0366-2023·2023-03-08

    Accord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations

    Accord Healthcare is recalling approximately 1.1 million bottles of Aripiprazole 5mg tablets due to Good Manufacturing Practice deviations identified during an FDA inspection. No illnesses or injuries have been reported.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0397-2023·2023-03-08

    Prescription Glycopyrrolate Injection Recalled Due to Manufacturing Process Deviations

    Accord Healthcare is recalling Glycopyrrolate Injection due to manufacturing process deviations found during FDA inspection. The recall involves 5,273 vials distributed across the United States, Puerto Rico, and Canada.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    1 state
  • 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-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
  • HighFDA (Drugs)·D-0427-2023·2023-03-08

    Ropinirole tablets recalled due to manufacturing practice deviations

    Accord Healthcare is recalling Ropinirole 1 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses have been reported.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    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-0358-2023·2023-03-08

    Injectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure

    FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 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 69374-315-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0379-2023·2023-03-08

    FDA recalls Buspirone Hydrochloride tablets for manufacturing practice deviations

    Accord Healthcare is recalling approximately 25,812 bottles of Buspirone Hydrochloride 30mg tablets due to manufacturing practice deviations discovered during an FDA inspection.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state