NDC 68180-339
Metformin Hydrochloride 1000 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 # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 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
- 1000 mg
- Approval
- ANDA ANDA091664
- On the market since
- Feb 1, 2016
- Package NDCs
68180-339-0168180-339-0268180-339-09- Official label
- DailyMed (National Library of Medicine), updated Sep 7, 2026
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