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 Actavis Laboratories, FL, Inc. Due to Failed Dissolution Specifications: Low Out-of-Specification results for the...

Date: September 25, 2015
Company: Actavis Laboratories, FL, 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 Actavis Laboratories, FL, 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 0591-2720-60; UPC 3 05912 72060 3.

Quantity: 13,284 bottles

Why Was This Recalled?

Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Actavis Laboratories, FL, Inc.

Actavis Laboratories, FL, Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

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