Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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Sterility & contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.

6,317 FDA drug recalls with this cause, newest first.

This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.

Class II · Moderate risk

Tri-Mix # 6

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

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

Tri-Mix # 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-1020-2016
Class II · Moderate risk

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-1019-2016
Class II · Moderate risk

Tri-Mix # 3

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

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

Tri-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-1017-2016
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