Metformin Hydrochloride Extended-Release Tablets — Class II drug recall D-0192-2025
Terminated recall by Granules Pharmaceuticals Inc., reported 2025-01-15. Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformi
| Recall number | D-0192-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules Pharmaceuticals Inc., Chantilly, VA, United States |
| Recall initiated | 2024-12-30 |
| Classified | 2025-01-08 |
| Reported by FDA | 2025-01-15 |
| Terminated | 2026-01-15 |
| Quantity | 6,804 bottles |
| NDC | 82009-0117, 82009-0117-10, 82009-0118, 82009-0118-01 |
| Lot numbers | 4911311A |
| Expiration dates | 2025-11 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0192-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.