Class III · Lower riskRecall completed
Valsartan Tablets USP
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: VR417062A, Exp. 09/2019; VR417063A, VR417064A, Exp. 10/2019
Where it was soldProduct was distributed throughout the United States to wholesalers and retailers.
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
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
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 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA foreign manufacturer
| Distributed by / for | Jubilant Cadista Pharmaceuticals, Inc. |
| NDC | 59746-363-90 |
Show the full FDA record
| Full product label | Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Distribution | Product was distributed throughout the United States to wholesalers and retailers. |
| Quantity | 7,048 bottles |
| Recall initiated | 2018-08-14 |
| Report date | 2018-08-29 |
| Recall completed | 2020-01-08 |
| Recall number | D-1106-2018 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Salisbury MD 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.