Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
RxRecalls Get alerts

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

Fentanyl 5

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-1728-2015
Class II · Moderate risk

Betamethasone Sodium Phosphate

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-1727-2015
Class II · Moderate risk

B-Complex 100 mg/ml Injection

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-1726-2015
Class II · Moderate risk

Baclofen 2

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-1725-2015
Class II · Moderate risk

Vitatrim Active Injectable

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-1724-2015
Class II · Moderate risk

Vitatrim Injection

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-1723-2015
Class II · Moderate risk

Tri-Mix (15 mg/0.5 mg/20 mcg)

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-1722-2015
Class II · Moderate risk

Tri-Mix Injectable

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-1721-2015
Class II · Moderate risk

Tri-Mix Super Injectable

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-1720-2015
Class II · Moderate risk

Tri-Mix (1/1/40)

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-1719-2015
Class II · Moderate risk

Quad-Mix 4 Injectable

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-1718-2015
Class II · Moderate risk

Quad-Mix 2 Injectable

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-1717-2015
Class II · Moderate risk

Quad-Mix 1 Injectable

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-1716-2015
Class II · Moderate risk

MYO-DEN Injection

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-1715-2015
Class II · Moderate risk

Myers Cocktail Injection

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-1714-2015
Class II · Moderate risk

Morphine 60 mg/ml + Fentanyl 12

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-1713-2015
Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 20

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-1712-2015
Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 3

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-1710-2015
Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 3

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-1709-2015
Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 2

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-1708-2015
Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 10

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-1707-2015
Class II · Moderate risk

Morphine 50 mg/ml + Fentanyl 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-1706-2015