US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 19, 2013 (13 years ago)

Glimepiride Tablets USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

What was recalled

GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.

Recalling firm
Qualitest Pharmaceuticals
NDC code
0603-3745-21
Origin
AL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-298-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Glimepiride recalls

See all
Class III · Low risk Ongoing

Glimepiride Tablets

Reason Misprint on tablet

Dr. Reddy's Laboratories, Inc. D-0313-2024
Class III · Low risk Ongoing

Glimepiride Tablets

Reason Misprint on tablet

Dr. Reddy's Laboratories, Inc. D-0312-2024
Class II · Moderate risk Terminated

Glimepiride USP

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0587-90 D-0559-2023
Class II · Moderate risk Ongoing

Glimepiride Tablets USP

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8066-9 D-0527-2023
Class II · Moderate risk Ongoing

Glimepiride Tablets

Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Preferred Pharmaceuticals, Inc. NDC 68788-8095-9 D-0517-2023