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

Estradiol 8 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1476-2015
Class II · Moderate risk

Estradiol 6 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1475-2015
Class II · Moderate risk

Estradiol 50 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1474-2015
Class II · Moderate risk

Estradiol 4 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1473-2015
Class II · Moderate risk

Estradiol 3 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1472-2015
Class II · Moderate risk

Estradiol 25 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1471-2015
Class II · Moderate risk

Estradiol 22 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1470-2015
Class II · Moderate risk

Estradiol 20 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1469-2015
Class II · Moderate risk

Estradiol 18 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1468-2015
Class II · Moderate risk

Estradiol 15 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1467-2015
Class II · Moderate risk

Estradiol 12.5 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1466-2015
Class II · Moderate risk

Estradiol 100 mg

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1465-2015
Class II · Moderate risk

Estradiol 10 mg Sterile Pellet

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1464-2015
Class II · Moderate risk

Cyanocobalamin 1

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1460-2015
Class II · Moderate risk

Cyanocobalamin 1

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1459-2015
Class II · Moderate risk

Cyanocobalamin 10 mg Pellet

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1458-2015
Class II · Moderate risk

Cyanocobalamin 1

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1457-2015
Class II · Moderate risk

Copper (Cupric)

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1456-2015
Class II · Moderate risk

Collagenase 250 units/ml

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1455-2015
Class II · Moderate risk

Clotrimazole 2% Otic Suspension

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1454-2015