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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2001–2025 of 11819

  • HighFDA (Drugs)·D-0364-2023·2023-03-08

    Sterile Water for Injection Recalled Due to Manufacturing Quality Deviations

    Nephron Sc Inc recalls 325,080 vials of Sterile Water for Injection due to manufacturing quality deviations that could result in product carryover. Affected lots expire December 31, 2023.

    Product
    STERILE WATER — STERILE WATER (STERILE WATER)
    Category
    Drug
    Distribution
    0 states
  • 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-0391-2023·2023-03-08

    Finasteride Tablets 1 mg Recalled for Manufacturing Quality Deviations

    Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.

    Product
    Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2
    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-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-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-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-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-0423-2023·2023-03-08

    FDA Recalls Pravastatin Sodium Tablets Due to Manufacturing Deviations

    Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 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-0362-2023·2023-03-08

    Phenylephrine injection recalled due to lack of sterility assurance

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.

    Product
    Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 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 69374-321-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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-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-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-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-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-0334-2023·2023-03-01

    Levothyroxine oral solution TIROSINT recalled nationwide for subpotency

    IBSA Pharma voluntarily recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency concerns. Affected lots are 220416 (Exp. 10/2023) and 221053 (Exp. 4/2024).

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0341-2023·2023-03-01

    Thyroid Drug TIROSINT Recalled Due to Subpotent Formulation

    IBSA Pharma Inc. recalls TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotent formulation containing less active ingredient than labeled.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0342-2023·2023-03-01

    FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency

    IBSA Pharma Inc. voluntarily recalled specific lots of TIROSINT (levothyroxine sodium) Oral Solution nationwide due to subpotency. The affected medication contains less active ingredient than labeled.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0336-2023·2023-03-01

    Levothyroxine Oral Solution TIROSINT Recalled Due to Subpotency

    IBSA PHARMA is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency in specific batches. The affected product may contain less active ingredient than labeled.

    Product
    TIROSINT — TIROSINT (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0338-2023·2023-03-01

    Thyroid Medication TIROSINT Levothyroxine Sodium Nationwide Recall for Subpotency

    IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. Two lot numbers are affected: Lot #220407 (Exp. 10/2023) and Lot #220960 (Exp. 03/2024).

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