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.

Metformin HCL E/R 500 mg Recalled by Direct Rx Due to CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above...

Date: October 12, 2020
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

Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90

Quantity: 88 bottles

Why Was This Recalled?

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Where Was This Sold?

This product was distributed to 1 state: FL

Affected (1 state)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