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 Teva Pharmaceuticals USA Inc Due to CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in...

Date: February 22, 2023
Company: Teva Pharmaceuticals USA Inc
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 Teva Pharmaceuticals USA Inc directly.

Affected Products

Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60

Quantity: 12,044 Bottles

Why Was This Recalled?

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Teva Pharmaceuticals USA Inc

Teva Pharmaceuticals USA Inc has 20 total recalls tracked by RecallDetector.

Related Recalls

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