Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Glimepiride recalled?

Yes — there is an active recall. 6 ongoing FDA recalls mention Glimepiride (21 total). Check the affected lots below.

Most common reason: cGMP deviation (15 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Glimepiride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Glimepiride recalls on record

none so far in 2026; 21 on record, newest first
Class III · Low risk

Glimepiride Tablets

Misprint on tablet

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

Glimepiride Tablets

Misprint on tablet

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

Glimepiride USP

CGMP deviations.

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

Glimepiride Tablets USP

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

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

Glimepiride Tablets

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

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8095-9 D-0517-2023
Class II · Moderate risk

Glimepiride Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Amerisource Health Services LLC NDC 68001-179-00 D-0759-2023
Class II · Moderate risk

Glimepiride Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Amerisource Health Services LLC NDC 68001-178-00 D-0758-2023
Class II · Moderate risk

Glimepiride Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Amerisource Health Services LLC NDC 68001-177-00 D-0757-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0250-30 D-0482-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0488-30 D-0481-2023
Class II · Moderate risk

Glimepiride

cGMP deviations

Terminated cGMP deviation Direct Rx NDC 61919-0723-30 D-0480-2023
Class II · Moderate risk

Glimepiride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-003-01 D-0395-2023
Class II · Moderate risk

Glimepiride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-002-01 D-0394-2023
Class II · Moderate risk

Glimepiride Tablets USP

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-001-01 D-0393-2023
Class II · Moderate risk

Glimepiride Tablets

Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.

Terminated Stability / shelf life Micro Labs Usa, Inc S NDC 42571-101-01 D-0046-2015
Class II · Moderate risk

GLIMEPIRIDE Tablet

Labeling:Label Mixup; GLIMEPIRIDE, Tablet, 1 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD73525_4, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-622-2014
Class II · Moderate risk

Glimepiride Tablets USP

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

Terminated Failed specification Qualitest Pharmaceuticals NDC 0603-3745-21 D-298-2013