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

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.

Jun 2, 2015 Class II · Moderate risk

MIC-B COMPLEX 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-1578-2015

Jun 2, 2015 Class II · Moderate risk

MIC+Methylcobalamin 4000 mcg/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-1577-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50…

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-1576-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 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-1575-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml 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-1574-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 25

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-1573-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 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-1572-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 4

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-1571-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 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-1570-2015

Jun 2, 2015 Class II · Moderate risk

Methylcobalamin 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-1569-2015

Jun 2, 2015 Class II · Moderate risk

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml 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-1568-2015

Jun 2, 2015 Class II · Moderate risk

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml 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-1567-2015

Jun 2, 2015 Class II · Moderate risk

Mannitol 5% 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-1566-2015

Jun 2, 2015 Class II · Moderate risk

Magnesium Sulfate 500 mg/ml 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-1565-2015

Jun 2, 2015 Class II · Moderate risk

Magnesium Chloride 200 mg/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-1564-2015

Jun 2, 2015 Class II · Moderate risk

Lidocaine 2% with Epinephrine 1:100

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-1563-2015

Jun 2, 2015 Class II · Moderate risk

Lidocaine 1% 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-1562-2015

Jun 2, 2015 Class II · Moderate risk

L-Arginine 100 mg/ml 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-1561-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxyprogesterone Caproate

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-1560-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml 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-1559-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 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-1558-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 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-1557-2015

Jun 2, 2015 Class II · Moderate risk

Hydroxocobalamin 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-1556-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 70 mg/ml Solution

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-1555-2015

Jun 2, 2015 Class II · Moderate risk

Hydromorphone 65 mg/ml Solution

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-1554-2015