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Medicines recallMHRA

Fingolimod Zentiva 0.5 mg Capsules recalled over possible contamination

Contamination or sterilityHigh riskClass 2

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.

Check your product

Only products that match these details are covered. Have your pack in front of you.

3 identifiers listed for this notice.

  • Fingolimod Zentiva 0.5 mg Capsules 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 4L01372H
    ExpiryOn the carton, blister or label.
    • 11/2027
    First distributedOn the product, its label or its packaging.
    • 28 January 2025

What to do now

The concern with Fingolimod Zentiva 0.5 mg Capsules is contamination or loss of sterility.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

Symptoms and when to get help

Look out for

  • redness, swelling or pain where the product was used
  • a high temperature

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/37). Quoted as issued.

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.

The risk

DMRC reference number DMRC - 39754868 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the affected batch. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

If patients have the affected batch they should contact their pharmacy in the first instance. Do not stop taking your medication without speaking to your healthcare professional first. The particles, if present, are known to be small and pose a low risk to the safety of the product. Patients with this batch are not considered at risk and no reports of harm have been reported for this batch of capsules.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Advice for patients

If patients have the affected batch they should contact their pharmacy in the first instance. Do not stop taking your medication without speaking to your healthcare professional first. The particles, if present, are known to be small and pose a low risk to the safety of the product. Patients with this batch are not considered at risk and no reports of harm have been reported for this batch of capsules.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Open the MHRA notice

Questions

Why has Fingolimod Zentiva 0.5 mg Capsules been recalled?

The concern with Fingolimod Zentiva 0.5 mg Capsules is contamination or loss of sterility. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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