Class IIReported 2025-04-16

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.

Recalled by Glenmark Pharmaceuticals Inc., USA

Reason for Recall

CGMP Deviations

Recall Number

D-0328-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-03-13

Reported

2025-04-16

Distribution

U.S. Nationwide

Code Info

Lot # 17232088, exp. date Sep-25 17232093, exp. date Sep-25

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.