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

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Hcg 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-1532-2015
Class II · Moderate risk

Hcg 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-1531-2015
Class II · Moderate risk

Hcg 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-1530-2015
Class II · Moderate risk

Hcg 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-1529-2015
Class II · Moderate risk

Hcg 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-1528-2015
Class II · Moderate risk

Hcg 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-1527-2015
Class II · Moderate risk

Hcg 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-1526-2015
Class II · Moderate risk

Hcg 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-1525-2015
Class II · Moderate risk

Hcg 11

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-1524-2015
Class II · Moderate risk

Hcg 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-1523-2015
Class II · Moderate risk

HCG 625 IU/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-1522-2015
Class II · Moderate risk

Hcg 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-1521-2015
Class II · Moderate risk

Hcg 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-1520-2015
Class II · Moderate risk

Hcg 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-1519-2015
Class II · Moderate risk

Hcg 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-1518-2015
Class II · Moderate risk

Hcg 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-1517-2015
Class II · Moderate risk

Hcg 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-1516-2015
Class II · Moderate risk

HCG 625 IU/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-1515-2015
Class II · Moderate risk

HCG 625 IU/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-1514-2015
Class II · Moderate risk

HCG 625 IU/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-1513-2015
Class II · Moderate risk

Hcg 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-1512-2015
Class II · Moderate risk

Hcg 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-1511-2015
Class II · Moderate risk

Hcg 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-1510-2015
Class II · Moderate risk

Hcg 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-1509-2015
Class II · Moderate risk

Hcg 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-1508-2015

Recalls by year