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

Morphine 70 mg/ml + Clonidine 1

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

The Compounding Pharmacy of America D-1615-2015
Class II · Moderate risk Terminated

Morphine 70 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-1614-2015
Class II · Moderate risk Terminated

Morphine 64 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-1613-2015
Class II · Moderate risk Terminated

Morphine 60 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-1612-2015
Class II · Moderate risk Terminated

Morphine 50 mg/ml +Fentanyl 1

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

The Compounding Pharmacy of America D-1611-2015
Class II · Moderate risk Terminated

Morphine 50 mg/ml + Clonidine 200 mcg/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-1610-2015
Class II · Moderate risk Terminated

Morphine 50 mg/ml + Clonidine 100 mcg/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-1609-2015
Class II · Moderate risk Terminated

Morphine 50 mg/ml + Bupivacaine 2.5 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-1608-2015
Class II · Moderate risk Terminated

Morphine 50 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-1607-2015
Class II · Moderate risk Terminated

Morphine 45 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-1606-2015
Class II · Moderate risk Terminated

Morphine 45 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-1605-2015
Class II · Moderate risk Terminated

Morphine 42 mg/ml + Bupivacaine 8 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-1604-2015
Class II · Moderate risk Terminated

Morphine 40 mg/ml + Fentanyl 2

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

The Compounding Pharmacy of America D-1603-2015
Class II · Moderate risk Terminated

Morphine 40 mg/ml + Clonidine 500 mcg/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-1602-2015
Class II · Moderate risk Terminated

Morphine 40 mg/ml + Bupivacaine 8 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-1601-2015
Class II · Moderate risk Terminated

Morphine 40 mg/ml + Bupivacaine 16 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-1600-2015
Class II · Moderate risk Terminated

Morphine 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-1599-2015
Class II · Moderate risk Terminated

Morphine 36 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-1598-2015
Class II · Moderate risk Terminated

Morphine 35 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-1597-2015
Class II · Moderate risk Terminated

Morphine 33 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-1596-2015
Class II · Moderate risk Terminated

Morphine 30 mg/ml + Clonidine 250 mcg/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-1595-2015
Class II · Moderate risk Terminated

Morphine 30 mg/ml + Bupivacaine 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-1594-2015
Class II · Moderate risk Terminated

Morphine 30 mg/ml + Baclofen 10 mcg/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-1593-2015
Class II · Moderate risk Terminated

Morphine 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-1592-2015
Class II · Moderate risk Terminated

Morphine 25 mg/ml + Baclofen 100 mcg/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-1591-2015