buPROPrion Hydrochloride Extended-Release Tablets — Class II drug recall D-0761-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-05-31, distributed nationwide. Failed Dissolution Specifications; during stability testing
| Recall number | D-0761-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-05-09 |
| Classified | 2023-05-23 |
| Reported by FDA | 2023-05-31 |
| Terminated | 2024-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 5,344 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 | HAC2240A, HAC3162A |
| Expiration dates | 2023-05, 2023-07 |
Product
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Reason for recall
Failed Dissolution Specifications; during stability testing
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-0761-2023. 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.