BuPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-855-2013
Terminated recall by Actavis Inc, reported 2013-08-14, distributed nationwide. Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specifica
| Recall number | D-855-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-08-08 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 15,132 bottles |
| Reason classes | specification failure |
| NDC | 67767-0142-30 |
| Lot numbers | 06/14, CG2D18A |
Product
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Reason for recall
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
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-855-2013. 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.