Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Read and act on the official notice on GOV.UK
The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
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 this recall | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | 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.
In plain English, for the pharmacy team
Why is this relevant to community pharmacy
Fingolimod Zentiva 0.5 mg Capsules is a capsule medicine used to treat Multiple Sclerosis. Zentiva is recalling one batch because of a possible metal particle contamination. This may affect pharmacies that may hold stock. Pharmacy staff may be asked about supplies or handle patient queries.
What to tell patients
Use your professional judgement for each patient.
- If you have this batch, contact your pharmacy in the first instance.
- Do not stop taking your medicine without speaking to your healthcare professional first.
- If you have any side effects or questions about the medicine, seek medical attention.
- Patients with this batch are not considered at risk and no reports of harm have been reported for this batch of capsules.
- Any suspected side effects should be reported through the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme.
What needs to be done
- Stop supplying the affected batch.
- Quarantine all remaining stock of the batches listed in the notice.
- Return the stock to your supplier using your supplier’s approved process.
- Pharmacy staff: if a patient asks about this batch, use the advice in the notice and report any suspected adverse reactions through the MHRA Yellow Card scheme.
- Read and act on the official GOV.UK notice.
Pharmshark summary, checked and approved by Chris Dotchin on 2 Nov 2026. It is not the official notice: always read and act on the GOV.UK notice.
How this summary was written
An AI tool drafted it from the MHRA's own notice and nothing else. A second check compared every line with the notice. Pharmshark's clinical lead then read it against the notice, edited it where needed and approved it. If the MHRA changes the notice, this summary is taken down until it has been checked again.
The MHRA's summary
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles.
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 Zentiva 0.5 mg Capsules | |||
| 4L01372H | 11/2027 | 28 | 28 January 2025 |
MHRA's audience tags: Dispensing GP practices, Pharmacy