Bupropion Hydrochloride Extended-Release Tablets — Class III drug recall D-0137-2017
Terminated recall by Amerisource Health Services, reported 2016-11-23, distributed nationwide. Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification res
| Recall number | D-0137-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services, Columbus, OH, United States |
| Recall initiated | 2016-10-27 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-06-29 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68001-0264-03, 68001-0264-05 |
| Expiration dates | 2018-03-31, 2018-04-30 |
Product
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Reason for recall
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
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-0137-2017. 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.