FDA Drug · D-0328-2025

Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.

Class II · Ongoing

CGMP Deviations

Affected lots / codes — check yours against thisLot # 17232088, exp. date Sep-25 17232093, exp. date Sep-25

Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: N/A
Distribution: U.S. Nationwide
Recall initiated: March 13, 2025
Classified: April 8, 2025
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-0328-2025%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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