Class IITerminated

Metformin Hydrochloride Extended-Release Tablets recall

FDA recall D-0192-2025 · initiated Dec 30, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was 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.

Details

Product: 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
Recalling company: Granules Pharmaceuticals Inc
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Distributor in OH.
Initiated: Dec 30, 2024
FDA report date: Jan 15, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0192-2025 ↗

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