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 Recalled by Direct Rx Due to cGMP deviations

Date: March 13, 2023
Company: Direct Rx
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 Direct Rx directly.

Affected Products

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Quantity: 30 count: 12 bottles; 90 count: 253 bottles

Why Was This Recalled?

cGMP deviations

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Direct Rx

Direct Rx has 36 total recalls tracked by RecallDetector.

Related Recalls

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