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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2976–3000 of 18005

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-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-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-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-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-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-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-0405-2023·2023-03-08
Accord Healthcare recalls Rosuvastatin tablets for manufacturing deviations
Accord Healthcare is recalling Rosuvastatin 10 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses or injuries have been reported.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
1 state
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

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