NDC 68180-338
Metformin Hydrochloride 500 mg tablet, extended release
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Nagpur, India | Makes it and packages it | Problems found, fixed voluntarilyJul 11, 2023 · 4 inspections |
Recalls
- Jul 7, 2020 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: Batch# G808201 Aug-20 G808202 Aug-20 G808200 Aug-20 G900935 Dec-20 G901311 Dec-20 G900957 Dec-20 G900958 Dec-20 G901006 Dec-20 G904803 May-21 G904804 May-21 G906551 Jul-21 G906552 Jul-21 G907375 Aug-21 G908605 Oct-21 G908604 Oct-21 G002108 Jan-22 G002109 Jan-22 G002559 Feb-22 G…
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, extended release, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA091664
- On the market since
- Feb 1, 2016
- Package NDCs
68180-338-0168180-338-0268180-338-03- Official label
- DailyMed (National Library of Medicine), updated Sep 7, 2026
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