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

Papaverine/Phentolamine/PGE-1 Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1381-2015
Class II · Moderate risk

Cyanocobalamin 500 mcg/mL Injectable

Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Terminated Sterility / contamination Liberty Drug & Surgical D-1380-2015
Class II · Moderate risk

Trypan Blue 0.3%

Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.

Terminated Sterility / contamination Vital Care Compounder D-1056-2016
Class II · Moderate risk

Brilliant Blue G BBG

Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.

Terminated Sterility / contamination Vital Care Compounder D-1055-2016
Class II · Moderate risk

Methylcobalamin 5

Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.

Terminated Sterility / contamination Vital Care Compounder D-1054-2016
Class II · Moderate risk

Tri-Mix T-106

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-1807-2015
Class II · Moderate risk

Tri-Mix T-105

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-1806-2015
Class II · Moderate risk

Tri-Mix T-102

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-1804-2015
Class II · Moderate risk

Tri-Mix T-101

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-1803-2015
Class II · Moderate risk

Tri-Mix SUPER

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-1802-2015
Class II · Moderate risk

Tri-Mix ST9E

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-1801-2015
Class II · Moderate risk

Tri-Mix ST9C

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-1800-2015
Class II · Moderate risk

Tri-Mix ST9A

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-1799-2015
Class II · Moderate risk

Tri-Mix ST9A

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-1798-2015
Class II · Moderate risk

Tri-Mix ST4

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-1796-2015
Class II · Moderate risk

Tri-Mix ST2

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-1793-2015

Recalls by year