Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

6,161 recalls · Class II, 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

Tri-Mix (18 mg/0.6 mg/5.88 mcg)

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-1767-2015
Class II · Moderate risk

Tri-Mix (17.7/0.59/6)

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-1766-2015
Class II · Moderate risk

Tri-Mix (17.7 mg/1 mg/10 mcg)

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-1765-2015
Class II · Moderate risk

Tri-Mix (17.7 mg/0.59 mg/6 mcg)

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-1764-2015
Class II · Moderate risk

Tri-Mix (17 mg/0.5 mg/6 mcg)

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-1763-2015
Class II · Moderate risk

Tri-Mix (15 mg/0.5 mg/5 mcg)

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-1762-2015
Class II · Moderate risk

Tri-Mix (10/0.174/16)

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-1761-2015
Class II · Moderate risk

Testosterone Cypionate 40 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-1757-2015
Class II · Moderate risk

Testosterone 70 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-1750-2015
Class II · Moderate risk

Testosterone 60 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-1749-2015
Class II · Moderate risk

Testosterone 37.5 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-1748-2015
Class II · Moderate risk

Testosterone 30 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-1747-2015
Class II · Moderate risk

Testosterone 25 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-1746-2015
Class II · Moderate risk

Testosterone 200 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-1745-2015
Class II · Moderate risk

Testosterone 20 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-1744-2015
Class II · Moderate risk

Testosterone 12.5 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-1743-2015

Recalls by year