Valsartan Tablets USP — Class III drug recall D-0876-2018
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2018-06-13, distributed in IN, MI, MS, NC, NJ, NY, OH. Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size
| Recall number | D-0876-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2018-05-25 |
| Classified | 2018-06-15 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-01-08 |
| Distributed | IN, MI, MS, NC, NJ, NY, OH |
| Reason classes | undeclared allergen |
| NDC | 59746-0363-90 |
| Lot numbers | VR417065A, VR417066A |
| Expiration dates | 2019-10 |
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 for recall
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0876-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.