FDA Drug Recalls

14,806 recalls, newest first

Jun 2, 2015 Class II · Moderate risk

Vancomycin 25 mg/ml Ophthalmic 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-1661-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 75 mg and B12 6 mg Pellet

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-1660-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 200 mg Anastrazole 9 mg Pellet

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-1659-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 200 mg Anastrazole 1 mg Pellet

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-1658-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 60 mg Anastrazole 4 mg Pellet

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-1657-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 80 mg Pellet

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-1656-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 75 mg Pellet

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-1655-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 72.5 mg Pellet

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-1654-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 70 mg Pellet

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-1653-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 62.5 mg Pellet

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-1652-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 50 mg Pellet

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-1651-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone USP

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-1650-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Propionate 100 mg/ml 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-1649-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone USP Aqueous 200 mg/ml 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-1648-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Enanthate 200 mg/ml 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-1647-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50

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-1646-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml 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-1645-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml 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-1644-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml 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-1643-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial

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-1642-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial

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-1641-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 100 mg/ml 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-1640-2015

Jun 2, 2015 Class II · Moderate risk

SUPER LIPO 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-1639-2015

Jun 2, 2015 Class II · Moderate risk

Sufentanil 50 mcg/ml + Bupivacaine 0.25 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-1638-2015

Jun 2, 2015 Class II · Moderate risk

Sufentanil 50 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-1637-2015

Recalls by year

2026572
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