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 Hydrochloride Extended-Release Tablets Recalled by Nostrum Laboratories Inc Due to CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above...

Date: October 23, 2020
Company: Nostrum Laboratories Inc
Status: Ongoing
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 Nostrum Laboratories Inc directly.

Affected Products

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

Quantity: 12,967 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nostrum Laboratories Inc

Nostrum Laboratories Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

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