FDA Drug Recalls

1,464 recalls · Class II, newest first

Jun 2, 2015 Class II · Moderate risk

PGE 150 (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-1620-2015

Jun 2, 2015 Class II · Moderate risk

Oxytocin 100 units/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-1619-2015

Jun 2, 2015 Class II · Moderate risk

Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment

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-1618-2015

Jun 2, 2015 Class II · Moderate risk

Nandrolone Decanoate 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-1617-2015

Jun 2, 2015 Class II · Moderate risk

Nandrolone Decanoate 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-1616-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 70 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-1615-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 70 mg/ml + Bupivacaine 40 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-1614-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 64 mg/ml + Bupivacaine 10 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-1613-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 60 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-1612-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 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-1611-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 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-1610-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/ml + Clonidine 100 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-1609-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 mg/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-1608-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 50 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-1607-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 45 mg/ml + Bupivacaine 40 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-1606-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 45 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-1605-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 42 mg/ml + Bupivacaine 8 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-1604-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 40 mg/ml + Fentanyl 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-1603-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 40 mg/ml + Clonidine 500 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-1602-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 40 mg/ml + Bupivacaine 8 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-1601-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 40 mg/ml + Bupivacaine 16 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-1600-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 40 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-1599-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 36 mg/ml + Bupivacaine 40 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-1598-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 35 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-1597-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 33 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-1596-2015

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