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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1976–2000 of 11852

  • 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
  • HighFDA (Drugs)·D-0399-2023·2023-03-08

    Glycopyrrolate Injection Recalled Due to Manufacturing Quality Deviations

    Accord Healthcare is recalling Glycopyrrolate Injection (4 mg/20 mL) from two batches due to CGMP deviations identified during FDA inspection. No illnesses have been reported.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    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-0355-2023·2023-03-08

    Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles distributed nationwide.

    Product
    Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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-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-0408-2023·2023-03-08

    Prescription Drug Simvastatin Recalled for Manufacturing Deviations

    Accord Healthcare is recalling Simvastatin 5 mg tablets distributed in the United States, Puerto Rico, and Canada. The recall follows an FDA inspection that identified manufacturing practice deviations.

    Product
    SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
    Category
    Drug
    Distribution
    1 state
  • 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-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-0402-2023·2023-03-08

    Phenylephrine Hydrochloride Injection Recalled for Manufacturing Practice Deviations

    Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.

    Product
    Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton
    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-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-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-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-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-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-0330-2023·2023-03-01

    Tacrolimus Capsules Recalled for Wrong-Strength Tablets Co-Mingled in Bottles

    Dr. Reddy's Laboratories is recalling Tacrolimus 0.5 mg capsules due to the presence of one 1 mg capsule co-mingled in affected bottles. The mismatched capsule could lead to incorrect dosing in immunosuppressed patients.

    Product
    TACROLIMUS — TACROLIMUS (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0331-2023·2023-03-01

    Prescription drug TIROSINT levothyroxine recalled for subpotent formulation

    IBSA Pharma has recalled two lots of TIROSINT levothyroxine sodium oral solution nationwide because they contain less active ingredient than labeled. The affected lots are 220409 (expiring 10/2023) and 220956 (expiring 03/2024).

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0335-2023·2023-03-01

    Prescription Thyroid Medication TIROSINT Recalled for Subpotent Dosages Nationwide

    IBSA Pharma is recalling certain lots of TIROSINT (levothyroxine sodium) oral solution nationwide because the product contains less active ingredient than labeled. Patients using affected lots may not receive adequate thyroid hormone replacement.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0345-2023·2023-03-01

    Prescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency

    IBSA Pharma has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Affected lots 220418 and 220560 may contain insufficient active ingredient for proper thyroid hormone replacement therapy.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0339-2023·2023-03-01

    Levothyroxine sodium oral solution recalled due to subpotency

    IBSA Pharma Inc. has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Some doses may contain less active ingredient than labeled. Patients should contact their healthcare provider.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide