Class II · ModerateRecall completed
Metformin Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch # 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 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22
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 foreign manufacturer
| Brand name | METFORMIN HYDROCHLORIDE |
| Generic name | METFORMIN HYDROCHLORIDE |
| Active ingredient(s) | METFORMIN HYDROCHLORIDE |
| Distributed by / for | Lupin Pharmaceuticals, Inc |
| NDC | 68180-339-09 |
Show the full FDA record
| Full product label | Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Distribution | Product was distributed throughout the United States. |
| Quantity | 95,886 bottles |
| Recall initiated | 2020-07-07 |
| Report date | 2020-07-22 |
| Recall completed | 2021-12-23 |
| Recall number | D-1383-2020 |
| 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.