FDA Drug recall D-0192-2025
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hydera…
- FDA Drug
- Class II
- terminated
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hydera… by Granules Pharmaceuticals, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0192-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-12-30 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Granules Pharmaceuticals |
| Distribution | OH |
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
Reason
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.
Identifiers
| ndc | 82009-117-10 |
|---|---|
| ndc | 82009-118-01 |
| code_info | Lot #: 4911311A, Exp. Date: 11/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0192-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.