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 17762

HighFDA (Drugs)·D-0536-2023·2023-04-26
Verapamil Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications
Amerisource Health Services LLC is recalling Verapamil Hydrochloride Extended-Release Tablets 180 mg due to failed dissolution specifications affecting lots 1008622 and 1010026 distributed nationwide.
Product
Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0537-2023·2023-04-26
CVS Earwax Removal Drops Recalled for Subpotent Active Ingredient
CVS-distributed earwax removal drops containing carbamide peroxide are being recalled because the active ingredient may degrade and become subpotent before the labeled expiration date, potentially leaving the product ineffective.
Product
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0531-2023·2023-04-19
Bevacizumab Injection Recall Due to Incorrect Lot Number Labeling
Pine Pharmaceuticals is recalling 932 syringes of Bevacizumab 2.5 mg/0.1 mL due to incorrect lot number labeling on the primary packaging. The affected lot (#66377, expiration 06/28/2023) was distributed nationwide.
Product
Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Offic
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0530-2023·2023-04-19
Pantoprazole Sodium Tablets Recalled for CGMP Deviations and Discoloration
Hetero USA Inc. is recalling 2,352 bottles of Pantoprazole Sodium 40mg tablets due to manufacturing deviations that caused discoloration. The affected lot (PAN22542, exp. 9/2024) was distributed nationwide.
Product
PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0529-2023·2023-04-19
Drug Injection Recall: Norepinephrine Bitartrate Impurity Above Specification
Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.
Product
NOREPINEPHRINE BITARTRATE — NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0532-2023·2023-04-19
Prescription Drug Recall: Incorrect Expiration Date on MEKTOVI Labels
Pfizer recalls 1,926 bottles of MEKTOVI (binimetinib) due to incorrect expiration dates on labels. Bottles labeled March 2026 actually expire February 2025.
Product
MEKTOVI — MEKTOVI (BINIMETINIB)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0535-2023·2023-04-19
Prescription Epinephrine Kits Recalled for Incorrect NDC Number on Carton
Focus Health Group is recalling 246 kits of Epinephrine Professional nationwide due to an incorrect NDC number printed on the outer carton. The labeling error does not affect the drug's safety or effectiveness.
Product
EPINEPHRINE PROFESSIONAL — EPINEPHRINE PROFESSIONAL (EPINEPHRINE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0521-2023·2023-04-12
Pravastatin Sodium Tablets Recalled Due to Manufacturing Deviations
Preferred Pharmaceuticals is recalling Pravastatin Sodium 20 mg tablets nationwide due to manufacturing practice deviations identified during FDA inspection. No illnesses have been reported.
Product
Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0507-2023·2023-04-12
Alprazolam 0.5 mg tablets recalled due to manufacturing contamination
Direct Rx is recalling Alprazolam 0.5 mg tablets (Lot 11AP2219, expires 4/30/23) nationwide due to potential cross-contamination concerns at the manufacturer. No illnesses have been reported.
Product
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0525-2023·2023-04-12
Simvastatin Tablets Recalled Due to Manufacturing Practice Deviations
Preferred Pharmaceuticals is recalling Simvastatin 40 mg tablets nationwide due to manufacturing practice violations at the production facility. The recall is precautionary.
Product
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0518-2023·2023-04-12
Montelukast Sodium Tablets Recalled for Manufacturing Deviations
Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets, USP, 10 mg due to current Good Manufacturing Practice deviations discovered during an FDA inspection. The product was distributed nationwide.
Product
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0522-2023·2023-04-12
Simvastatin Tablets Recalled Due to Manufacturing Compliance Deviations
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 10 mg due to manufacturing compliance deviations identified at Accord Healthcare. No illnesses or injuries have been reported.
Product
Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0523-2023·2023-04-12
Simvastatin Tablets, USP, 80 mg Recalled Due to Manufacturing Deviations
Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 80 mg due to manufacturing quality control deviations identified at Accord Healthcare during FDA inspection. Approximately 57 bottles distributed nationwide.
Product
Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0489-2023·2023-04-12
Testosterone Cypionate Injection Recalled for Manufacturing Defect
Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection due to complaints that crystals fail to redissolve after warming and shaking, a manufacturing quality defect affecting specific lots nationwide.
Product
TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0492-2023·2023-04-12
Doxazosin 2 mg tablets recalled for manufacturing practice deviations
RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.
Product
Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0498-2023·2023-04-12
Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations
RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.
Product
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0501-2023·2023-04-12
Rosuvastatin 10mg tablets recalled for manufacturing process deviations
RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets due to cGMP deviations in the manufacturing process. The recall affects 30-count and 90-count bottles distributed nationwide.
Product
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0513-2023·2023-04-12
Clopidogrel Tablets 75 mg Recalled for Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.
Product
Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0506-2023·2023-04-12
Alprazolam 1mg tablets recalled for manufacturing contamination risk
Preferred Pharmaceuticals is recalling Alprazolam 1mg tablets due to manufacturing deviations that created a potential cross-contamination risk. Affected lots expire August 2024.
Product
Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0504-2023·2023-04-12
Alprazolam 0.25mg tablets recalled for potential cross contamination
Preferred Pharmaceuticals is recalling Alprazolam 0.25mg tablets (Lot G1822K, expiration 5/31/2023) nationwide due to potential cross contamination from manufacturing deviations. No illnesses have been reported.
Product
Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0505-2023·2023-04-12
Alprazolam 0.5mg Tablets Recalled Due to Potential Cross Contamination
Preferred Pharmaceuticals is recalling Alprazolam 0.5mg tablets nationwide due to CGMP manufacturing deviations at Breckenridge Pharmaceuticals that created a potential cross-contamination risk.
Product
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0520-2023·2023-04-12
Rosuvastatin Tablets Recalled Due to Manufacturing Deviations
Preferred Pharmaceuticals is recalling 264 bottles of Rosuvastatin Tablets 5mg nationwide due to manufacturing deviations discovered during FDA inspection. No illnesses have been reported.
Product
Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0494-2023·2023-04-12
Ropinirole 0.5 mg tablets recalled for manufacturing quality deviations
RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets due to manufacturing process deviations. The product was distributed nationwide within the United States.
Product
Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0496-2023·2023-04-12
Simvastatin 10 mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. voluntarily recalled Simvastatin 10 mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lots distributed to consignees throughout the United States.
Product
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0510-2023·2023-04-12
Montelukast Sodium Oral Granules Recalled for Failed Impurity Specifications
Teva is recalling Montelukast Sodium Oral Granules 4 mg (lot 3007556A) due to failed impurity specifications. The recall affects 3,772 cartons distributed nationwide.
Product
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Category
Drug
Distribution
Distributed nationwide

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2801–2825 of 17762