BuPROPion Hydrochloride Extended-release Tablets — Class III drug recall D-0670-2017
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2017-04-19, distributed nationwide. Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradati
| Recall number | D-0670-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2016-04-08 |
| Classified | 2017-04-13 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 81,077 bottles |
| Reason classes | specification failure |
| NDC | 59746-0316-01, 59746-0316-60 |
Product
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Reason for recall
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
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-0670-2017. 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.