US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

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

Quad-Mix #3

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

Well Care Compounding Pharmacy D-1025-2016
Class II · Moderate risk Terminated

Vitamin B Complex # 3

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

Well Care Compounding Pharmacy D-1024-2016
Class II · Moderate risk Terminated

Vitamin B Complex # 1

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

Well Care Compounding Pharmacy D-1023-2016
Class II · Moderate risk Terminated

Vancomycin 50mg/Ml Ophth Solution

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

Well Care Compounding Pharmacy D-1022-2016
Class II · Moderate risk Terminated

Tri-Mix # 6

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

Well Care Compounding Pharmacy D-1021-2016
Class II · Moderate risk Terminated

Tri-Mix # 5

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

Well Care Compounding Pharmacy D-1020-2016
Class II · Moderate risk Terminated

Tri-Mix # 4

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

Well Care Compounding Pharmacy D-1019-2016
Class II · Moderate risk Terminated

Tri-Mix # 3

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

Well Care Compounding Pharmacy D-1018-2016
Class II · Moderate risk Terminated

Tri-Mix # 2

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

Well Care Compounding Pharmacy D-1017-2016
Class II · Moderate risk Terminated

Tri-Mix # 1

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

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

Testosterone Cypionate 200mg/Ml

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

Well Care Compounding Pharmacy D-1015-2016
Class II · Moderate risk Terminated

Testosterone Cypionate 175mg/Ml

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

Well Care Compounding Pharmacy D-1014-2016
Class II · Moderate risk Terminated

Testosterone Cypionate 150mg/Ml

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

Well Care Compounding Pharmacy D-1013-2016
Class II · Moderate risk Terminated

Testosterone Cypionate 10mg/Ml

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

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

Testosterone Cypionate 100mg/Ml

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

Well Care Compounding Pharmacy D-1011-2016
Class II · Moderate risk Terminated

Super Tri-Mix #4

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

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

Super Tri-Mix #1

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

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

Quad-Mix #4

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

Well Care Compounding Pharmacy D-1008-2016
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