Class II · ModerateRecall completed
Metformin Hydrochloride Extended Release
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberM125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22
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 byMarksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India foreign manufacturer
| Brand name | METFORMIN HYDROCHLORIDE EXTENDED RELEASE |
| Generic name | METFORMIN HYDROCHLORIDE |
| Active ingredient(s) | METFORMIN HYDROCHLORIDE |
| Distributed by / for | Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA |
| NDC | 49483-624-01 |
Show the full FDA record
| Full product label | Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01 |
| Recalling firm | Marksans Pharma Limited |
| Distribution | Nationwide |
| Quantity | 368,976 bottles |
| Recall initiated | 2020-10-02 |
| Report date | 2020-11-11 |
| Recall completed | 2024-02-21 |
| Recall number | D-0062-2021 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Vasco Da Gama N/A India |
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.