APLENZIN¿ — Class III drug recall D-0051-2015
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2014-11-05, distributed nationwide. Labeling: Incorrect or Missing Package Insert
| Recall number | D-0051-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2014-06-05 |
| Classified | 2014-10-28 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2017-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 20,499 hdpe |
| Reason classes | labeling |
| NDC | 00024-5810-07 |
| Lot numbers | 03/17, 13E019P |
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 for recall
Labeling: Incorrect or Missing Package Insert
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-0051-2015. 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.