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

2801–2825 of 5063

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-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
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
0 states
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
0 states
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
0 states
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
0 states
HighFDA (Drugs)·D-0373-2023·2023-03-08
Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling 147,736 bottles of Atorvastatin Calcium 40 mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
0 states
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
0 states
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
0 states
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
0 states
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
0 states
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
0 states
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-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-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
0 states
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
0 states
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
0 states
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
0 states
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
0 states
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-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
0 states
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
0 states
HighFDA (Drugs)·D-0412-2023·2023-03-08
Accord Healthcare Simvastatin 80 mg Tablets Recalled for Manufacturing Practice Violations
Accord Healthcare is recalling Simvastatin 80 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. Approximately 205,631 bottles are affected across the US, Puerto Rico, and Canada.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
0 states
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-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

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2801–2825 of 5063