FDA Drug Recalls

1,464 recalls · Class II, newest first

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

Jun 2, 2015 Class II · Moderate risk

Sufentanil 45 mcg/ml + Bupivacaine 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-1636-2015

Jun 2, 2015 Class II · Moderate risk

Sodium Tetradecyl Sulfate 5% 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-1635-2015

Jun 2, 2015 Class II · Moderate risk

Sodium Ascorbate 500 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-1634-2015

Jun 2, 2015 Class II · Moderate risk

Sermorelin 300 mcg/ml + GHRP-2 300 mcg/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-1633-2015

Jun 2, 2015 Class II · Moderate risk

Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 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-1632-2015

Jun 2, 2015 Class II · Moderate risk

Sermorelin/GHRP6 1000/1000 mcg/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-1631-2015

Jun 2, 2015 Class II · Moderate risk

Sermorelin/GHRP2 1000/1000 mcg/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-1630-2015

Jun 2, 2015 Class II · Moderate risk

Sermorelin 1000 mcg/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-1629-2015

Jun 2, 2015 Class II · Moderate risk

Selenium 200 mcg/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-1628-2015

Jun 2, 2015 Class II · Moderate risk

Pyridoxine Hydrochloride 100 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-1627-2015

Jun 2, 2015 Class II · Moderate risk

Progesterone 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-1626-2015

Jun 2, 2015 Class II · Moderate risk

Polidocanol 5% 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-1625-2015

Jun 2, 2015 Class II · Moderate risk

Polidocanol 1% 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-1624-2015

Jun 2, 2015 Class II · Moderate risk

Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% 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-1623-2015

Jun 2, 2015 Class II · Moderate risk

PGE 80 (Alprostadil)

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-1622-2015

Jun 2, 2015 Class II · Moderate risk

PGE 40 (Alprostadil)

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-1621-2015

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