US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Quad-Mix #2

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

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

Quad-Mix #1

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

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

Phosphatidylcholine/Deoxycholic Acid- 5%/4.75%

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

Well Care Compounding Pharmacy D-1005-2016
Class II · Moderate risk Terminated

Phenylepherine 0.5%

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

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

Myers' Cocktail

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

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

Methylcobalamin/Folic Acid

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

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

Methylcobalamin 5mg/Ml

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

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

Methylcobalamin 1 Mg/Ml

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

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

Methylcobalamin 12.5mg/Ml

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

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

M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML

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

Well Care Compounding Pharmacy D-0998-2016
Class II · Moderate risk Terminated

Mb 12/Hxb 12/Fa/P5p/

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

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

M.l.C. Methyl B12

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

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

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

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

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

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

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

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

L-Glut/L-Arg/L-Carn

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

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

Levocarnitine 100mg/Ml

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

Well Care Compounding Pharmacy D-0992-2016
Class II · Moderate risk Terminated

Hydrogen Peroxide 3%

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

Well Care Compounding Pharmacy D-0991-2016
Class II · Moderate risk Terminated

Hcg/Methylcobalamin/Folic Acid

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

Well Care Compounding Pharmacy D-0990-2016
Class II · Moderate risk Terminated

1-Hcg 2000 Iu/Ml

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

Well Care Compounding Pharmacy D-0989-2016
Class II · Moderate risk Terminated

1-Hcg 1000 Iu/Ml

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

Well Care Compounding Pharmacy D-0988-2016
Class II · Moderate risk Terminated

Glutathione 200mg/Ml

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

Well Care Compounding Pharmacy D-0987-2016
Class II · Moderate risk Terminated

Glutathione 100mg/Ml

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

Well Care Compounding Pharmacy D-0986-2016
Class II · Moderate risk Terminated

GENTAMICIN 15 MG/ML Ophthalmic Solution

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

Well Care Compounding Pharmacy D-0985-2016
Class II · Moderate risk Terminated

Estradiol Valerate 40mg/Ml

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

Well Care Compounding Pharmacy D-0984-2016
Class II · Moderate risk Terminated

Estradiol Valerate 20mg/Ml

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

Well Care Compounding Pharmacy D-0983-2016