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

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
Class II · Moderate risk

Hydrogen Peroxide 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-0991-2016
Class II · Moderate risk

Hcg/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-0990-2016
Class II · Moderate risk

1-Hcg 2000 Iu/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-0989-2016
Class II · Moderate risk

1-Hcg 1000 Iu/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-0988-2016
Class II · Moderate risk

Glutathione 200mg/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-0987-2016
Class II · Moderate risk

Glutathione 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-0986-2016
Class II · Moderate risk

Estradiol Valerate 40mg/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-0984-2016
Class II · Moderate risk

Estradiol Valerate 20mg/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-0983-2016
Class II · Moderate risk

Estradiol Valerate 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-0982-2016
Class II · Moderate risk

Estradiol Cypionate 10 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-0981-2016
Class II · Moderate risk

Alpha Lipoic Acid 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-0979-2016
Class II · Moderate risk

17-0h Progesterone 250mg/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-0978-2016