Class II · ModerateRecall completed
Riomet
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: J190386A, X190354A, Exp. 3/2021, J190393A, Exp. 5/2021, A200035A, Exp. 6/2021, B200064A, Exp. 8/2021; H200236A, Exp. 1/2022
Where it was soldNationwide within 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
Microbial Contamination of Non-Sterile 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 byMikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512
| Brand name | RIOMET |
| Generic name | METFORMIN HYDROCHLORIDE |
| Active ingredient(s) | METFORMIN HYDROCHLORIDE |
| Distributed by / for | Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512 |
| NDC | 10631-206-02 |
Show the full FDA record
| Full product label | Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02. |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Distribution | Nationwide within the United States |
| Quantity | 13,834 bottles |
| Recall initiated | 2021-03-31 |
| Report date | 2021-04-21 |
| Recall completed | 2022-04-14 |
| Recall number | D-0334-2021 |
| 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.