Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Manufacturing (cGMP) deviations
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Captopril Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Famotodine Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Famotodine Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Famotodine 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
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
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
Zonisamide Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
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