Class II · ModerateRecall completed
Metformin Hydrochloride Extended-release Tablets USP
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch # G901203, exp. date 12/2020
Where it was soldProduct was distributed throughout the United States.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byLupin Limited Goa INDIA (NDC 68180-336-07) foreign manufacturer
| Distributed by / for | Lupin Pharmaceuticals, Inc., Baltimore, MD |
| NDC | 68180-336-07 |
Show the full FDA record
| Full product label | Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Distribution | Product was distributed throughout the United States. |
| Quantity | 6,540 bottles |
| Recall initiated | 2020-06-11 |
| Report date | 2020-07-01 |
| Recall completed | 2021-12-23 |
| Recall number | D-1334-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Baltimore MD United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.