Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Granules India Limited | Medchal-Malkajgiri District, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 14, 2020 · 6 inspections |
Recalls
- Dec 30, 2024 · Class II · Granules Pharmaceuticals Inc.
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.
Lots: Lot #: 4911311A, Exp. Date: 11/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metformin: every company that makes it
- Form
- tablet, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA209313
- On the market since
- Jul 25, 2023
- Package NDCs
82009-117-10- Official label
- DailyMed (National Library of Medicine), updated Dec 4, 2025
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