buPROPion Hydrochloride Extended-Release Tablets — Class III drug recall D-248-2013
Terminated recall by Actavis South Atlantic LLC, reported 2013-04-24, distributed nationwide. Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability tes
| Recall number | D-248-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis South Atlantic LLC, Sunrise, FL, United States |
| Recall initiated | 2013-03-22 |
| Classified | 2013-04-12 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-05-09 |
| Distributed | Nationwide (US) |
| Quantity | 555,672 bottles |
| Reason classes | specification failure |
| NDC | 67767-0142-30 |
| Lot numbers | 03/13, 04/13, 05/13, 07/13, 08/13, 10/13, 11/13, CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D03A, CE1D04A, CE1D05A, CE1D06A, CE1D07A, CE1D08A, CE1D13A, CE1D14A, CE1D15A, CE1D24A, CF1D01A, CF1D02A, CH1D08A, CH1D09A, CH1D10A, CH1D11A, CJ1D01A, CJ1D02A, CJ1D09A, CJ1D10A, CK1D05B, CK1D06A, CL1D05A and 4 more |
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.
Reason for recall
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour 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-248-2013. 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.