FDA Drug Recalls

1,464 recalls · Class II, newest first

Jun 2, 2015 Class II · Moderate risk

Morphine 30 mg/ml + Clonidine 250 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-1595-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 30 mg/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-1594-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 30 mg/ml + Baclofen 10 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-1593-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 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-1592-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 25 mg/ml + Baclofen 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-1591-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 20 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-1590-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free

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-1589-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 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-1588-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 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-1587-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 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-1586-2015

Jun 2, 2015 Class II · Moderate risk

Morphine 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-1585-2015

Jun 2, 2015 Class II · Moderate risk

Mitomycin 40 mg/50 ml Sodium Chloride 0.9% 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-1584-2015

Jun 2, 2015 Class II · Moderate risk

Mitomycin 40 mg/40 ml Sodium Chloride 0.9% 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-1583-2015

Jun 2, 2015 Class II · Moderate risk

Mitomycin 0.03% 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-1582-2015

Jun 2, 2015 Class II · Moderate risk

Mitomycin 0.02% 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-1581-2015

Jun 2, 2015 Class II · Moderate risk

MIC-PLUS Carnitine 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-1580-2015

Jun 2, 2015 Class II · Moderate risk

MIC-B12+B6 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-1579-2015

Jun 2, 2015 Class II · Moderate risk

MIC-B COMPLEX 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-1578-2015

Jun 2, 2015 Class II · Moderate risk

MIC+Methylcobalamin 4000 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-1577-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 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-1576-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 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-1575-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 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-1574-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 25

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-1573-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 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-1572-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 4

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-1571-2015

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