D-0192-2025 Class II Terminated
FDA drug recall D-0192-2025 was initiated by Granules Pharmaceuticals Inc. on Dec 30, 2024 and is designated Class II. 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. The recall status is terminated (terminated Jan 15, 2026). Affected quantity: 6,804 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 15, 2025
- Initiation Date
- Dec 30, 2024
- Termination Date
- Jan 15, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,804 bottles
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
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.
Distribution Pattern
Distributor in OH.
Code Information
Lot #: 4911311A, Exp. Date: 11/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0192-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026