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

2701–2725 of 5063

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-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-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-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-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
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-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-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-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-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
ModerateFDA (Drugs)·D-0516-2023·2023-04-12
Finasteride Tablets Recalled Due to Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling specific lots of Finasteride Tablets, 5 mg due to manufacturing process deviations discovered during FDA inspection of manufacturer Accord Healthcare. No illnesses or injuries have been reported.
Product
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2023·2023-04-12
Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations
RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.
Product
Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0527-2023·2023-04-12
Glimepiride Tablets Recall Due to Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.
Product
Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0502-2023·2023-04-12
Rosuvastatin 40mg tablets recalled nationwide for manufacturing process deviations
RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.
Product
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2023·2023-04-12
Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations
RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.
Product
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0491-2023·2023-04-12
Drug Recall: Atorvastatin 10 mg tablets due to manufacturing process violations
RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated March 20, 2023.
Product
Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0514-2023·2023-04-12
Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations
Preferred Pharmaceuticals recalls Doxazosin Tablets USP 2 mg (Lot H3122K, expires 5/31/2024) due to current Good Manufacturing Practice deviations identified at the manufacturing facility.
Product
Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0512-2023·2023-04-12
Atorvastatin Calcium Tablets 20 mg Recalled Due to Manufacturing Practice Deviations
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg nationwide due to manufacturing practice deviations at the manufacturer, Accord Healthcare, Inc., identified during FDA inspection.
Product
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2023·2023-04-12
Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns
Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.
Product
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2023·2023-04-12
Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.
Product
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0511-2023·2023-04-12
Atorvastatin Calcium Tablets Recalled for Manufacturing Process Deviations
Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets (10 mg) distributed nationwide due to manufacturing process deviations identified at Accord Healthcare. Affected lot numbers are A0523D, F14220, and J0622Q.
Product
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2023·2023-04-12
Drug Recall: Simvastatin tablets due to manufacturing deviations
RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.
Product
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0509-2023·2023-04-12
Alprazolam 2 mg tablets recalled due to potential manufacturing cross-contamination
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.
Product
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0497-2023·2023-04-12
Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations
RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.
Product
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Category
Drug
Distribution
Distributed nationwide

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2701–2725 of 5063