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 # 1

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1016-2016
Class II · Moderate risk

Testosterone Cypionate 10mg/Ml

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1012-2016
Class II · Moderate risk

Super Tri-Mix #4

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1010-2016
Class II · Moderate risk

Super Tri-Mix #1

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1009-2016
Class II · Moderate risk

Quad-Mix #4

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1008-2016
Class II · Moderate risk

Quad-Mix #2

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1007-2016
Class II · Moderate risk

Quad-Mix #1

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1006-2016
Class II · Moderate risk

Phenylepherine 0.5%

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1004-2016
Class II · Moderate risk

Myers' Cocktail

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1003-2016
Class II · Moderate risk

Methylcobalamin/Folic Acid

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1002-2016
Class II · Moderate risk

Methylcobalamin 5mg/Ml

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1001-2016
Class II · Moderate risk

Methylcobalamin 1 Mg/Ml

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1000-2016
Class II · Moderate risk

Methylcobalamin 12.5mg/Ml

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0999-2016
Class II · Moderate risk

Mb 12/Hxb 12/Fa/P5p/

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0997-2016
Class II · Moderate risk

M.l.C. Methyl B12

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0996-2016
Class II · Moderate risk

M.I.C. /Mb12/B6/Dexplan/L-Carn

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0995-2016
Class II · Moderate risk

M.l.C. 25MG/50MG/25MG/ML

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0994-2016
Class II · Moderate risk

L-Glut/L-Arg/L-Carn

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0993-2016
Class II · Moderate risk

Levocarnitine 100mg/Ml

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-0992-2016

Recalls by year