buPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-917-2013
Terminated recall by Actavis South Atlantic LLC, reported 2013-09-04, distributed nationwide. Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupro
| Recall number | D-917-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis South Atlantic LLC, Sunrise, FL, United States |
| Recall initiated | 2013-08-21 |
| Classified | 2013-08-23 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 428,268 bottles |
| Reason classes | specification failure |
| NDC | 67767-0142-30 |
| Lot numbers | 03/14, 04/14, 05/14, 06/14, 07/14, 08/14, 12/13, CA2D14A, CA2D15A, CD2D07A, CD2D08A, CD2D09A, CD2D09B, CD2D10A, CE2D05A, CE2D06A, CE2D07A, CE2D10A, CE2D11A, CE2D12A, CE2D19A, CF2D01A, CF2D02A, CF2D03A, CG2D04A, CG2D05A, CG2D07A, CG2D09A, CG2D12A, CH2D13A, CH2D14A, CH2D17A, CH2D18A, CH2D21A, CJ2D10A, CJ2D11A |
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: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
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-917-2013. 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.