FDA Drug recall D-0876-2018
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd
- FDA Drug
- Class III
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class III recall of Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd by Jubilant Cadista Pharmaceuticals, citing incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0876-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-05-25 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | IN, MI, MS, NC, NJ, NY, OH |
Product
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Reason
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Identifiers
| code_info | Lot #: VR417065A, VR417066A, Exp 10/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Jubilant Cadista Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0876-2018%22
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