buPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-1501-2016
Terminated recall by Amerisource Health Services, reported 2016-09-21, distributed nationwide. Failed dissolution specifications - the out of specification result for dissolution was identified during 3 mo
| Recall number | D-1501-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services, Columbus, OH, United States |
| Recall initiated | 2016-08-04 |
| Classified | 2016-09-15 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,626 bottles |
| Reason classes | specification failure |
| NDC | 68001-0264-03 |
| Lot numbers | 12/17, MS1509 |
Product
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Reason for recall
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month 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-1501-2016. 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.