buPROPion Hydrochloride Extended-release Tablets — Class III drug recall D-0007-2017
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2016-10-12, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0007-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2016-09-13 |
| Classified | 2016-10-06 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2018-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 31,762 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00347335737868 |
| 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 |
| Expiration dates | 2016-10 |
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 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-0007-2017. 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.