buPROPion Hydrochloride Extended Release Tablets — Class III drug recall D-892-2013
Terminated recall by American Health Packaging, reported 2013-08-21, distributed nationwide. Failed Stability Specifications; out of specification results at the 9 month stability time point for color, d
| Recall number | D-892-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2013-02-04 |
| Classified | 2013-08-15 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2013-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 389 cartons |
| Reason classes | specification failure |
| NDC | 68084-0470-01 |
| Lot numbers | 114500 |
Product
buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Reason for recall
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
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-892-2013. 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.