US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Alprostadil 50 mcg/ml Injection

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

The Compounding Pharmacy of America D-1440-2015
Class II · Moderate risk Terminated

Alprostadil 40 mcg/ml Injection

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

The Compounding Pharmacy of America D-1439-2015
Class II · Moderate risk Terminated

Alprostadil 20 mcg/ml Injection

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

The Compounding Pharmacy of America D-1438-2015
Class II · Moderate risk Terminated

Alprostadil 100 mcg/ml Injection

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

The Compounding Pharmacy of America D-1437-2015
Class II · Moderate risk Terminated

Alprostadil 10 mcg/ml Injection

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

The Compounding Pharmacy of America D-1436-2015
Class II · Moderate risk Terminated

Acetylcysteine 100 mg/ml Injectable

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

The Compounding Pharmacy of America D-1435-2015
Class II · Moderate risk Terminated

Acetyl-L-Carnitine 500 mg/ml

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

The Compounding Pharmacy of America D-1434-2015
Class II · Moderate risk Terminated

Acetyl-L-Carnitine 250 mg/ml Injectable

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

The Compounding Pharmacy of America D-1433-2015
Class II · Moderate risk Terminated

5-Methy Tetrahydrofolate 5 mg/ml Injectable

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

The Compounding Pharmacy of America D-1432-2015
Class II · Moderate risk Terminated

5-Methyl Tetrahydrofolate

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

The Compounding Pharmacy of America D-1431-2015
Class II · Moderate risk Terminated

Zonisamide capsules

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Lisinopril tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Lisinopril tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Lisinopril tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Lisinopril tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-060-11 D-1226-2015
Class II · Moderate risk Terminated

Famotidine tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-172-11 D-1225-2015
Class II · Moderate risk Terminated

Clarithromycin tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-437-11 D-1224-2015
Class II · Moderate risk Terminated

Azithromycin tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-278-11 D-1223-2015
Class II · Moderate risk Terminated

Azithromycin tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-464-11 D-1222-2015
Class II · Moderate risk Terminated

Azithromycin tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-279-11 D-1221-2015
Class II · Moderate risk Terminated

Amlodipine besylate tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-506-11 D-1220-2015
Class II · Moderate risk Terminated

Amlodipine besylate tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-505-11 D-1219-2015
Class II · Moderate risk Terminated

Amlodipine besylate tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-498-11 D-1218-2015
Class II · Moderate risk Terminated

Enalapril maleate and hydrochlorothiazide tablets USP

Reason Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Apotex Inc. NDC 60505-0209-1 D-1215-2015
Class II · Moderate risk Terminated

Losartan potassium tablets USP

Reason Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Apotex Inc. NDC 60505-3161-9 D-1214-2015