Lupin Limited
Salcette, India · makes it and packages it
Problems found, fixed voluntarily Last FDA inspection Nov 21, 2025. 9 inspections on record, 1 with serious problems.
NDC 68180-337
Metformin Hydrochloride 1000 mg tablet, extended release
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
Recalls
- Jul 7, 2020 · Class II · Terminated
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots: Batch # G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-20 G807618 Jul-20 G808042 Jul-20 G808043 Jul-20 G807349 Jul-20 G807350 Jul-20 G807444 Jul-20 G807507 Jul-20 G807508 Jul-20 G807314 Jul-20 G807316 Jul-20 G807325 Jul-20 G…
Product details
- Generic drug
- Metformin: see every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 1000 mg
- Approval
- ANDA ANDA090692
- On the market since
- Sep 30, 2011
- Package NDCs
68180-337-0168180-337-0268180-337-07- Official label
- DailyMed (National Library of Medicine), updated Sep 9, 2026
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