BuPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-0519-2019
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2019-03-13. Failed Dissolution Specifications; 9-monthstability timepoint
| Recall number | D-0519-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2019-02-28 |
| Classified | 2019-03-06 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-03-05 |
| Reason classes | specification failure |
| NDC | 59746-0758-90 |
| Expiration dates | 2019-11 |
Product
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
Reason for recall
Failed Dissolution Specifications; 9-monthstability timepoint
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-0519-2019. 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.