Class II · ModerateRecall completed
RIOMET ER (metformin hydrochloride for extended-release oral suspension)
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: AB06381; Exp 10/2021
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 in finished drug product.
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 bySun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 foreign manufacturer
| Distributed by / for | Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 |
| NDC | 10631-019-17 |
Show the full FDA record
| Full product label | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Distribution | Nationwide |
| Quantity | 747 bottles |
| Recall initiated | 2020-09-23 |
| Report date | 2020-10-07 |
| Recall completed | 2021-11-03 |
| Recall number | D-0002-2021 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Princeton NJ 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.