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

Magnesium Sulfate 500 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-1565-2015
Class II · Moderate risk Terminated

Magnesium Chloride 200 mg/ml

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

The Compounding Pharmacy of America D-1564-2015
Class II · Moderate risk Terminated

Lidocaine 2% with Epinephrine 1:100

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

The Compounding Pharmacy of America D-1563-2015
Class II · Moderate risk Terminated

Lidocaine 1% Injection

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

The Compounding Pharmacy of America D-1562-2015
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-1561-2015
Class II · Moderate risk Terminated

Hydroxyprogesterone Caproate

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

The Compounding Pharmacy of America D-1560-2015
Class II · Moderate risk Terminated

Hydroxocobalamin 10 mg/ml Folic Acid 4 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-1559-2015
Class II · Moderate risk Terminated

Hydroxocobalamin 5

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

The Compounding Pharmacy of America D-1558-2015
Class II · Moderate risk Terminated

Hydroxocobalamin 10

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

The Compounding Pharmacy of America D-1557-2015
Class II · Moderate risk Terminated

Hydroxocobalamin 1

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

The Compounding Pharmacy of America D-1556-2015
Class II · Moderate risk Terminated

Hydromorphone 70 mg/ml Solution

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

The Compounding Pharmacy of America D-1555-2015
Class II · Moderate risk Terminated

Hydromorphone 65 mg/ml Solution

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

The Compounding Pharmacy of America D-1554-2015
Class II · Moderate risk Terminated

Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution

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

The Compounding Pharmacy of America D-1553-2015
Class II · Moderate risk Terminated

Hydromorphone 5 mg/ml Solution

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

The Compounding Pharmacy of America D-1552-2015
Class II · Moderate risk Terminated

Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution

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

The Compounding Pharmacy of America D-1551-2015
Class II · Moderate risk Terminated

Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution

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

The Compounding Pharmacy of America D-1550-2015
Class II · Moderate risk Terminated

Hydromorphone 30 mg/ml Solution

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

The Compounding Pharmacy of America D-1549-2015
Class II · Moderate risk Terminated

Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution

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

The Compounding Pharmacy of America D-1548-2015
Class II · Moderate risk Terminated

Hydromorphone 20 mg/ml Solution

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

The Compounding Pharmacy of America D-1547-2015
Class II · Moderate risk Terminated

Hydromorphone 15 mg/ml Solution

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

The Compounding Pharmacy of America D-1546-2015
Class II · Moderate risk Terminated

Hydromorphone 12.5 mg/ml Solution

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

The Compounding Pharmacy of America D-1545-2015
Class II · Moderate risk Terminated

Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution

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

The Compounding Pharmacy of America D-1544-2015
Class II · Moderate risk Terminated

Hydromorphone 10 mg/ml + Baclofen 2

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

The Compounding Pharmacy of America D-1543-2015
Class II · Moderate risk Terminated

Hydromorphone 10 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-1542-2015
Class II · Moderate risk Terminated

Hydromorphone 1 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-1541-2015