Class II · ModerateActive recall
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberN107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
Where it was soldIndiana - Nationwide.
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 (per manufacturer)
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
| Distributed by / for | Denton Pharma, Inc. |
| NDC | 70934-334-30 |
Show the full FDA record
| Full product label | Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30 |
| Recalling firm | Denton Pharma, Inc. |
| Distribution | Indiana - Nationwide. |
| Quantity | N/A |
| Recall initiated | 2020-10-08 |
| Report date | 2020-11-11 |
| Recall completed | — |
| Recall number | D-0056-2021 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | North Blenheim NY 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.