FDA Drug recall D-1104-2018
Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant…
- FDA Drug
- Class III
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class III recall of Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant… by Jubilant Cadista Pharmaceuticals, citing incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1104-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-14 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
Valsartan Tablets USP, 80 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 59746-361-90
Reason
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Identifiers
| ndc | 59746-360-30 |
|---|---|
| ndc | 59746-360-90 |
| ndc | 59746-360-05 |
| ndc | 59746-360-03 |
| ndc | 59746-361-30 |
| ndc | 59746-361-90 |
| ndc | 59746-361-05 |
| ndc | 59746-361-03 |
| ndc | 59746-362-30 |
| ndc | 59746-362-90 |
| ndc | 59746-362-05 |
| ndc | 59746-362-03 |
| ndc | 59746-393-30 |
| ndc | 59746-393-90 |
| ndc | 59746-393-67 |
| ndc | 59746-393-32 |
| code_info | Lot #: VR217013A, Exp. 08/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1104-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.