Ontozry
Ontozry Recall Summary Ontozry, an epilepsy medication containing cenobamate, is being recalled across the European Union due to adverse events that emerged after the drug was approved and released to the market. This is classified as a Class II recall, meaning the product could cause temporary or medically reversible adverse effects, but is unlikely to cause serious harm.
- Product
- Active substances: cenobamate. Therapeutic area: Epilepsy. ATC code: N03AX
- Reason
- Adverse event;Post-authorisation measure
- Classification
- Class II
- Category
- drug recall
- Country
- European Union
- Agency
- EMA-DHPC
- Recall date
- 2026-05-12
- Status
- Ongoing
- Distribution
- European Union
Official recall notice from EMA-DHPC
Recall details on Nibble Recalls: https://trynibble.app/recalls/4271e30a-cb56-4af1-878b-345f989b630a