Clozapine

Clozapine Recall Summary Clozapine, a medication containing the active substance clozapine, is being recalled across the European Union due to a safety signal that has been identified. This is a Class II recall, which means a potential health hazard exists. The recall affects clozapine products distributed throughout EU member states.

Product
Active substances: clozapine
Reason
Safety signal
Classification
Class II
Category
drug recall
Country
European Union
Agency
EMA-DHPC
Recall date
2025-09-08
Status
Ongoing
Distribution
European Union

Official recall notice from EMA-DHPC

Recall details on Nibble Recalls: https://trynibble.app/recalls/5d5b0b77-f18b-49c2-a541-b12c6e9ae06a