RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
Read and act on the official notice on GOV.UK
Class 3 recall — Action within 5 days.
The MHRA uses Class 3 when:
The defect is unlikely to cause harm to the patient.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 this recall | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
The MHRA's summary
Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches of Fingolimod SUN 0.5mg hard capsules are impacted.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| Fingolimod SUN 0.5mg hard capsules | |||
| HAF2945A | 30/11/2027 | 28 | 08/05/2025 |
MHRA's audience tags: Dispensing GP practices, Pharmacy