RecallRadar

FDA Drug recall D-175-2013

buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavi…

On 2013-03-06 the FDA classified a Class III recall of buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavi… by Actavis Pharmaceuticals, citing failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-175-2013
ClassificationClass III
Statusterminated
Initiated2013-01-04
Published2013-03-06
Last updated2026-09-13 11:51 UTC
CompanyActavis Pharmaceuticals
DistributionUS

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

Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

Identifiers

code_infoLot CB1D05A,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-175-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.