Mysimba

Mysimba is a weight-loss medication containing bupropion and naltrexone that is being recalled across the European Union due to adverse events. This recall is classified as Class II, meaning the product could cause serious health problems but is unlikely to result in death. The recall affects all users of this medication in EU countries.

Product
Active substances: bupropion hydrochloride;naltrexone hydrochloride. ATC code: A08AA
Reason
Adverse event
Classification
Class II
Category
drug recall
Country
European Union
Agency
EMA-DHPC
Recall date
2025-05-29
Status
Ongoing
Distribution
European Union

Official recall notice from EMA-DHPC

Recall details on Nibble Recalls: https://trynibble.app/recalls/ab1456a4-7437-4ae2-b0f8-ff6e64eea715