Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Glimepiride Tablets Recalled by Amerisource Health Services LLC Due to CGMP Deviations: recalling drug products following an FDA...

Date: March 17, 2023
Company: Amerisource Health Services LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Amerisource Health Services LLC directly.

Affected Products

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

Quantity: 129,849 bottles

Why Was This Recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Amerisource Health Services LLC

Amerisource Health Services LLC has 43 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report