FDA Drug recall D-1103-2018
Valsartan Tablets USP, 40 mg, 30-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, 40 mg, 30-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-1103-2018 |
| 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, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
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 #: VR117014A, VR117015A, 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.
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FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc
FDA Drug · Class III · 2022-04-13 · Jubilant Cadista Pharmaceuticals - Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadis…
FDA Drug · Class I · 2022-04-06 · Jubilant Cadista Pharmaceuticals
All Jubilant Cadista Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1103-2018%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.