FDA Drug recall D-0051-2015
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals…
- FDA Drug
- Class III
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class III recall of APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals… by Valeant Pharmaceuticals North America, citing labeling: Incorrect or Missing Package Insert.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0051-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-06-05 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
Product
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.
Reason
Labeling: Incorrect or Missing Package Insert
Identifiers
| code_info | Lot # 13E019P; Exp 03/17 |
|---|
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-0051-2015%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.