BuPROPion Hydrochloride Extended-Release Tablet — Class III drug recall D-1043-2014
Terminated recall by Actavis Inc, reported 2014-02-05, distributed nationwide. Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
| Recall number | D-1043-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2013-11-15 |
| Classified | 2014-01-29 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 139,944 bottles |
| Reason classes | specification failure |
| NDC | 00591-3331, 00591-3331-05, 00591-3331-19, 00591-3331-30 |
| Lot numbers | 521687A, 524099M, 524100A |
Product
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Reason for recall
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
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-1043-2014. 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.