Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Medicine |
| Medsafe Reference: | 36778 |
| Brand Name: | Evrysdi (Roche) |
| Dose Form/Strength: | Powder for oral solution 0.75 mg/mL |
| Affected: | |
| Recalling Organisation: | Roche Products (NZ) Ltd 98 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | |
| Manufacturer: | |
| Issue: | Multiple complaints from a pharmacy in Germany identified visible insoluble particles after reconstitution of Evrysdi® 0.75 mg/mL powder for oral solution. Particles were confirmed primarily as PTFE (Teflon), with sizes ~0.3-2.7 mm; minor quantities of PP/PE/PA/cellulose fibres also detected. Roche is proposing a DHCP letter and continue to supply the product. |
| Recall action type: | Communication to healthcare professionals |
| Recall action: | Product alert |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 15/5/2026 |
