RecallClass 3 · Action within 5 days
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
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
Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.
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 Glenmark 0.5 mg Hard Capsules | |||
| 1501919 | 29/02/2027 | 28 | 09/10/2025 |
MHRA's audience tags: Dispensing GP practices, Pharmacy