buPROPion Hydrochloride Extended — Class III drug recall D-175-2013
Terminated recall by Actavis Pharmaceuticals, reported 2013-03-06, distributed nationwide. Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
| Recall number | D-175-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Pharmaceuticals, Morristown, NJ, United States |
| Recall initiated | 2013-01-04 |
| Classified | 2013-02-27 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2014-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 14,856 bottles |
| Reason classes | specification failure |
| NDC | 67767-0142-30 |
| Lot numbers | CB1D05A |
Product
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Reason for recall
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
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-175-2013. 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.