FDA Drug Recalls

6,161 recalls · Class II, newest first

Jun 2, 2015 Class II · Moderate risk

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 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-1567-2015

Jun 2, 2015 Class II · Moderate risk

Mannitol 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-1566-2015

Jun 2, 2015 Class II · Moderate risk

Magnesium Sulfate 500 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-1565-2015

Jun 2, 2015 Class II · Moderate risk

Magnesium Chloride 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-1564-2015

Jun 2, 2015 Class II · Moderate risk

Lidocaine 2% with Epinephrine 1:100

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-1563-2015

Jun 2, 2015 Class II · Moderate risk

Lidocaine 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-1562-2015

Jun 2, 2015 Class II · Moderate risk

L-Arginine 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-1561-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxyprogesterone Caproate

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-1560-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 10 mg/ml Folic Acid 4 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-1559-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 5

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-1558-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 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-1557-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 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-1556-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 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-1555-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 65 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-1554-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Bupivacaine 30 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-1553-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 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-1552-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 40 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-1551-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 40 mg/ml + Bupivacaine 20 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-1550-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 30 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-1549-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 20 mg/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-1548-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 20 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-1547-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 15 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-1546-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 12.5 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-1545-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 10 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-1544-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 10 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-1543-2015

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