Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
FDA Drug Recalls
1,356 recalls, newest first
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations
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
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
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
Class II · Moderate risk
Zonisamide capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Famotidine tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Clarithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine besylate tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine besylate tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine besylate tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Clarithromycin Tablets
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Class II · Moderate risk
Captopril Tablets
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Class II · Moderate risk
Famotidine Tablets
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.