Valsartan Tablets USP — Class III drug recall D-1105-2018
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2018-08-29, distributed nationwide. Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufactu
| Recall number | D-1105-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2018-08-14 |
| Classified | 2018-08-17 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2020-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 18,947 bottles |
| Reason classes | undeclared allergen |
| NDC | 59746-0360, 59746-0360-03, 59746-0360-05, 59746-0360-30, 59746-0360-90, 59746-0361, 59746-0361-03, 59746-0361-05, 59746-0361-30, 59746-0361-90, 59746-0362, 59746-0362-03, 59746-0362-05, 59746-0362-30, 59746-0362-90, 59746-0393, 59746-0393-30, 59746-0393-32, 59746-0393-67, 59746-0393-90 |
| Lot numbers | VR317040A, VR317041A, VR317042A, VR317043A |
| Expiration dates | 2019-08 |
Product
Valsartan Tablets USP, 160 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 59746-362-90
Reason for recall
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
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-1105-2018. 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.