Granules Pharmaceuticals Inc.: Drug Recall

Recall #D-0192-2025 · 12/30/2024

Class II: Risk

Recall Details

Recall Number
D-0192-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Granules Pharmaceuticals Inc.
Status
Terminated
Date Initiated
12/30/2024
Location
Chantilly, VA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,804 bottles

Reason for Recall

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.

Product Description

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

Distribution Pattern

Distributor in OH.

Other Recalls by Granules Pharmaceuticals Inc.

View all recalls by Granules Pharmaceuticals Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.