buPROPion Hydrochloride Extended Release Tablets USP — Class III drug recall D-1446-2016
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2016-07-27, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1446-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2016-06-27 |
| Classified | 2016-07-20 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2018-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 16,085 bottles |
| Reason classes | specification failure |
| NDC | 47335-0736, 47335-0736-08, 47335-0736-13, 47335-0736-86, 47335-0736-88, 47335-0737, 47335-0737-08, 47335-0737-13, 47335-0737-86, 47335-0737-88, 47335-0738, 47335-0738-08, 47335-0738-13, 47335-0738-86, 47335-0738-88 |
| Lot numbers | JKN3477A |
| Expiration dates | 2016-07 |
Product
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Reason for recall
Failed Dissolution Specifications
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-1446-2016. 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.