FDA Drug · D-0192-2025

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

Class II · Terminated

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.

Affected lots / codes — check yours against thisLot #: 4911311A, Exp. Date: 11/2025

Recalling firm: Granules Pharmaceuticals Inc., Chantilly, VA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 6,804 bottles
Distribution: Distributor in OH.
Recall initiated: December 30, 2024
Classified: January 8, 2025
Terminated: January 15, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0192-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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