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Medicines recallMHRA

Fingolimod 0.5 mg Hard Capsules recalled over a strength or dose problem

Wrong strength or doseMedium riskClass 3

Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.

Check your product

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

11 identifiers listed for this notice.

  • Fingolimod 0.5 mg Hard Capsules 28

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 1306526
    • 1306528
    • 1400709
    • 1400710
    Product licenceThe PL number on the carton.
    • PL 25258/0323
    ExpiryOn the carton, blister or label.
    • 31-May-2025
    • 30-Nov-2025
    First distributedOn the product, its label or its packaging.
    • 17-Oct-2023
    • 06-Feb-2024
    • 27-Feb-2024
    • 15-Mar-2024

What to do now

Fingolimod 0.5 mg Hard Capsules has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

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

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.

An affected pack bought over the counter can be returned to where you bought it.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/39). Quoted as issued.

Summary

Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.

The risk

MDR number MDR 113-05/23 Company name

Advice for healthcare professionals

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

No further action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

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

No further action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

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 0.5 mg Hard Capsules been recalled?

Fingolimod 0.5 mg Hard Capsules has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

How do I know if my medicine is affected?

Compare the batch code, product licence, 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?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.

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