Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2015

Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,733 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2015 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Cholecalciferol 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-1450-2015
Class II · Moderate risk

Biotin10 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-1446-2015
Class II · Moderate risk

Baclofen 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-1445-2015
Class II · Moderate risk

B-Complex 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-1444-2015
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-1441-2015
Class II · Moderate risk

Alprostadil 50 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-1440-2015
Class II · Moderate risk

Alprostadil 40 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-1439-2015
Class II · Moderate risk

Alprostadil 20 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-1438-2015
Class II · Moderate risk

Alprostadil 10 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-1436-2015
Class II · Moderate risk

Acetyl-L-Carnitine 500 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-1434-2015
Class II · Moderate risk

5-Methyl Tetrahydrofolate

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-1431-2015
Class II · Moderate risk

Zonisamide capsules

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-008-11 D-1230-2015
Class II · Moderate risk

Lisinopril tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-064-11 D-1229-2015
Class II · Moderate risk

Lisinopril tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-062-11 D-1228-2015
Class II · Moderate risk

Lisinopril tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-061-11 D-1227-2015
Class II · Moderate risk

Lisinopril tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-060-11 D-1226-2015

Recalls by year