FDA Drug Recalls

1,711 recalls, newest first

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1704-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1703-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1702-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1701-2015

Jun 2, 2015 Class II · Moderate risk

MEGA-BURN* Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1700-2015

Jun 2, 2015 Class II · Moderate risk

MEGA-BURN III Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1699-2015

Jun 2, 2015 Class II · Moderate risk

MEGA-BURN IV Injectable

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1698-2015

Jun 2, 2015 Class II · Moderate risk

MEGA-BURN Injectable ROCK CREEK

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1697-2015

Jun 2, 2015 Class II · Moderate risk

MEGA-BURN Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1696-2015

Jun 2, 2015 Class II · Moderate risk

Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1695-2015

Jun 2, 2015 Class II · Moderate risk

Lipovicine Modified II Injectable

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1694-2015

Jun 2, 2015 Class II · Moderate risk

Lipotropic Methyl B-12 Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1693-2015

Jun 2, 2015 Class II · Moderate risk

Lipotropic B-12 II* + Lidocaine Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1692-2015

Jun 2, 2015 Class II · Moderate risk

Lipotropic B-12 Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1691-2015

Jun 2, 2015 Class II · Moderate risk

Lipotropic

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1690-2015

Jun 2, 2015 Class II · Moderate risk

Lipo-Vite III

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1689-2015

Jun 2, 2015 Class II · Moderate risk

LIPO-VITE Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1688-2015

Jun 2, 2015 Class II · Moderate risk

LIPO-Tropic Injectable

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1687-2015

Jun 2, 2015 Class II · Moderate risk

LIPO-EXTREME Injectable

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1686-2015

Jun 2, 2015 Class II · Moderate risk

LIPO-DEN MODIFIED Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1685-2015

Jun 2, 2015 Class II · Moderate risk

Lipo-DEN III Injection

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1684-2015

Jun 2, 2015 Class II · Moderate risk

Lipo-B MMC I

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1683-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1682-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 mg/ml +Fentanyl 16

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1681-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1680-2015

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061