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

Pge 2

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

The Compounding Pharmacy of America D-1740-2015
Class II · Moderate risk Terminated

Myo-Den

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

The Compounding Pharmacy of America D-1739-2015
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-1738-2015
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-1737-2015
Class II · Moderate risk Terminated

Morphine 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-1736-2015
Class II · Moderate risk Terminated

Mega-Burn

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

The Compounding Pharmacy of America D-1735-2015
Class II · Moderate risk Terminated

LIPOLEAN + Ascorbic Acid 50 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-1734-2015
Class II · Moderate risk Terminated

LIPOLEAN Injectable

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

The Compounding Pharmacy of America D-1733-2015
Class II · Moderate risk Terminated

Hydromorphone 80 mg/ml + Fentanyl 15

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

The Compounding Pharmacy of America D-1732-2015
Class II · Moderate risk Terminated

Hydromorphone 80 mg/ml + Fentanyl 15

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

The Compounding Pharmacy of America D-1731-2015
Class II · Moderate risk Terminated

Hydromorphone 80 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-1730-2015
Class II · Moderate risk Terminated

Hydromorphone 70 mg/ml+Fentanyl 16

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

The Compounding Pharmacy of America D-1729-2015
Class II · Moderate risk Terminated

Fentanyl 5

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

The Compounding Pharmacy of America D-1728-2015
Class II · Moderate risk Terminated

Betamethasone Sodium Phosphate

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

The Compounding Pharmacy of America D-1727-2015
Class II · Moderate risk Terminated

B-Complex 100 mg/ml Injection

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

The Compounding Pharmacy of America D-1726-2015
Class II · Moderate risk Terminated

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-1725-2015
Class II · Moderate risk Terminated

Vitatrim Active Injectable

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

The Compounding Pharmacy of America D-1724-2015
Class II · Moderate risk Terminated

Vitatrim Injection

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

The Compounding Pharmacy of America D-1723-2015
Class II · Moderate risk Terminated

Tri-Mix

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

The Compounding Pharmacy of America D-1722-2015
Class II · Moderate risk Terminated

Tri-Mix Injectable

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

The Compounding Pharmacy of America D-1721-2015
Class II · Moderate risk Terminated

Tri-Mix Super Injectable

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

The Compounding Pharmacy of America D-1720-2015
Class II · Moderate risk Terminated

Tri-Mix

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

The Compounding Pharmacy of America D-1719-2015
Class II · Moderate risk Terminated

Quad-Mix 4 Injectable

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

The Compounding Pharmacy of America D-1718-2015
Class II · Moderate risk Terminated

Quad-Mix 2 Injectable

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

The Compounding Pharmacy of America D-1717-2015
Class II · Moderate risk Terminated

Quad-Mix 1 Injectable

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

The Compounding Pharmacy of America D-1716-2015