Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,724 recalls · Class II, newest first

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

Repaskin 30

cGMP Deviations; product does not comply with cGMP requirements

Ongoing cGMP deviation Sesderma, SL NDC 63181-0012-1 D-0845-2016
Class II · Moderate risk

Repaskin 50

cGMP Deviations; product does not comply with cGMP requirements

Ongoing cGMP deviation Sesderma, SL NDC 63181-0013-1 D-0844-2016
Class II · Moderate risk

Lisinopril Tablets USP

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Terminated cGMP deviation Wockhardt Usa Inc. NDC 64679-941-06 D-1347-2015
Class II · Moderate risk

Lisinopril Tablets USP

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Terminated cGMP deviation Wockhardt Usa Inc. NDC 64679-928-06 D-1346-2015
Class II · Moderate risk

Clonidine Hydrochloride Tablets

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Terminated cGMP deviation Mutual Pharmaceutical Company, Inc. NDC 53489-217-01 D-1282-2015
Class II · Moderate risk

Clonidine Hydrochloride Tablets

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Terminated cGMP deviation Mutual Pharmaceutical Company, Inc. NDC 53489-216-01 D-1281-2015
Class II · Moderate risk

Clonidine Hydrochloride Tablets

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Terminated cGMP deviation Mutual Pharmaceutical Company, Inc. NDC 53489-215-01 D-1280-2015
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
Class II · Moderate risk

Famotidine tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Clarithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Azithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Azithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Azithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Amlodipine besylate tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Amlodipine besylate tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

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

Amlodipine besylate tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-498-11 D-1218-2015

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