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.

Recall Number: D-0328-2025

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Ongoing

Report Date: 20250416

Initiation Date: 20250313

Termination Date:

Reason for Recall

CGMP Deviations

Product Description

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.