US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Estradiol 100 mg

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1465-2015
Class II · Moderate risk Terminated

Estradiol 10 mg Sterile Pellet

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1464-2015
Class II · Moderate risk Terminated

Dmps

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1463-2015
Class II · Moderate risk Terminated

Dexpanthenol 250 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1462-2015
Class II · Moderate risk Terminated

Dexpanthenol 215 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1461-2015
Class II · Moderate risk Terminated

Cyanocobalamin 1

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1460-2015
Class II · Moderate risk Terminated

Cyanocobalamin 1

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1459-2015
Class II · Moderate risk Terminated

Cyanocobalamin 10 mg Pellet

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1458-2015
Class II · Moderate risk Terminated

Cyanocobalamin 1

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1457-2015
Class II · Moderate risk Terminated

Copper

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1456-2015
Class II · Moderate risk Terminated

Collagenase 250 units/ml

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1455-2015
Class II · Moderate risk Terminated

Clotrimazole 2% Otic Suspension

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1454-2015
Class II · Moderate risk Terminated

Cholecalciferol 600

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1453-2015
Class II · Moderate risk Terminated

Cholecalciferol 500

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1452-2015
Class II · Moderate risk Terminated

Cholecalciferol 100

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1451-2015
Class II · Moderate risk Terminated

Cholecalciferol 50

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1450-2015
Class II · Moderate risk Terminated

Bupivacaine 15 mg/ml Intrathecal Solution

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1449-2015
Class II · Moderate risk Terminated

Brompheniramine Maleate 20 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1447-2015
Class II · Moderate risk Terminated

Biotin10 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1446-2015
Class II · Moderate risk Terminated

Baclofen 1

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1445-2015
Class II · Moderate risk Terminated

B-Complex Injection

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1444-2015
Class II · Moderate risk Terminated

Ascorbic Acid 500 mg/ml Injectable Vial

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1442-2015
Class II · Moderate risk Terminated

L-Arginine 100 mg/ml Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1441-2015