FDA Drug Recalls

6,161 recalls · Class II, newest first

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

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 7

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-1679-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 15

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-1678-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 20

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-1677-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 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-1676-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 50 mg/ml + Fentanyl 3

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-1675-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 45 mg/ml + Fentanyl 10

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-1674-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 35 mg/ml + Bupivacaine 4 mg/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-1673-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 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-1672-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 3 mg/ml + Baclofen 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-1671-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 20 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-1670-2015

Jun 2, 2015 Class II · Moderate risk

Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 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-1669-2015

Jun 2, 2015 Class II · Moderate risk

Calmme 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-1668-2015

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