Class II · ModerateActive recall
Metformin Hydrochloride Extended-Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberMET100201, MET100401 EXP 05/2022
Where it was soldNationwide
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: detection of 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 byNostrum Laboratories, Inc. Kansas City, MO 64120
| Distributed by / for | Nostrum Laboratories Inc |
| NDC | 29033-055-01 |
Show the full FDA record
| Full product label | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01 |
| Recalling firm | Nostrum Laboratories Inc |
| Distribution | Nationwide |
| Quantity | 20,872 bottles |
| Recall initiated | 2020-10-23 |
| Report date | 2020-11-11 |
| Recall completed | — |
| Recall number | D-0068-2021 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Kansas City MO 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.