FDA Drug Recalls

1,070 recalls, newest first

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (30/0.5/10)

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-1774-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (25/2.5/10)

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-1773-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (25/2.5/10)

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-1772-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (22.5/0.83/8.3)

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-1771-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (20/2.5/20)

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-1770-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (20/1/10)

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-1769-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (18/0.6/5.88)

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-1768-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (18 mg/0.6 mg/5.88 mcg)

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-1767-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (17.7/0.59/6)

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-1766-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (17.7 mg/1 mg/10 mcg)

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-1765-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (17.7 mg/0.59 mg/6 mcg)

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-1764-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (17 mg/0.5 mg/6 mcg)

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-1763-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (15 mg/0.5 mg/5 mcg)

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-1762-2015

Jun 2, 2015 Class II · Moderate risk

Tri-Mix (10/0.174/16)

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-1761-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Tri-Blend 200 mg/ml

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-1760-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 40 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-1759-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 250 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-1758-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 40 mg/ml

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-1757-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 220 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-1756-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 250 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-1755-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Cypionate 50 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-1754-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 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-1753-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 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-1752-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 87.5 mg Sterile 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-1751-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 70 mg

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-1750-2015

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