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 Granules Pharmaceuticals Inc. Due to Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg...

Date: December 30, 2024
Company: Granules Pharmaceuticals 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 Granules Pharmaceuticals Inc. directly.

Affected Products

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10

Quantity: 6,804 bottles

Why Was This Recalled?

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Where Was This Sold?

This product was distributed to 1 state: OH

Affected (1 state)Not affected

About Granules Pharmaceuticals Inc.

Granules Pharmaceuticals Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

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