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Independent register of U.S. FDA drug recalls · updated Oct 12, 2026

Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 recalls, newest first.

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 80 mg/ml + Bupivacaine 10 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-1682-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 mg/ml +Fentanyl 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-1681-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal 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-1680-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 7

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-1679-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 15

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-1678-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 mg/ml + Fentanyl 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-1677-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 60 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-1676-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 50 mg/ml + Fentanyl 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-1675-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 45 mg/ml + Fentanyl 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-1674-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal 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-1673-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 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-1672-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 3 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-1671-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 20 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-1670-2015

Jun 2, 2015 Class II · Moderate risk

Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal 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-1669-2015

Jun 2, 2015 Class II · Moderate risk

Calmme 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-1668-2015

Jun 2, 2015 Class II · Moderate risk

Buckshot 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-1667-2015

Jun 2, 2015 Class II · Moderate risk

Bi-Mix Medium

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-1666-2015

Jun 2, 2015 Class II · Moderate risk

Bi-Mix (20/1)

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-1665-2015

Jun 2, 2015 Class II · Moderate risk

Bi-Mix #1 (17.365 mg/0.59 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-1664-2015

Jun 2, 2015 Class II · Moderate risk

Zinc Chloride 25mg/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-1663-2015

Jun 2, 2015 Class II · Moderate risk

Zinc 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-1662-2015

Jun 2, 2015 Class II · Moderate risk

Vancomycin 25 mg/ml 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-1661-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 75 mg and B12 6 mg 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-1660-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 200 mg Anastrazole 9 mg 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-1659-2015

Jun 2, 2015 Class II · Moderate risk

Testosterone 200 mg Anastrazole 1 mg 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-1658-2015

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