Class II · ModerateRecall completed
Valsartan
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberVR120022A
Where it was soldFL, GA, SC
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: Intermittent exposure to temperature excursion during storage.
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 byJubilant Generics Ltd. Roorkee-247661, India foreign manufacturer
| Brand name | VALSARTAN |
| Generic name | VALSARTAN |
| Active ingredient(s) | VALSARTAN |
| Distributed by / for | Cardinal Health Inc. |
| NDC | 59746-360-30 |
Show the full FDA record
| Full product label | Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India |
| Recalling firm | Cardinal Health Inc. |
| Distribution | FL, GA, SC |
| Quantity | 20 bottles |
| Recall initiated | 2021-03-15 |
| Report date | 2021-06-02 |
| Recall completed | 2024-06-17 |
| Recall number | D-0461-2021 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Dublin OH 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.