FDA Drug recall D-1043-2014
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-333…
- FDA Drug
- Class III
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class III recall of BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-333… by Actavis, citing failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1043-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-11-15 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Actavis |
| Distribution | US |
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
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Identifiers
| ndc | 0591-3331-30 |
|---|---|
| ndc | 0591-3331-19 |
| ndc | 0591-3331-05 |
| code_info | Lots: 524099M, 524100A, 521687A |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1043-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.