Medicines recallMHRA
Fingolimod SUN 0.5mg hard capsules recalled over a packaging defect
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.
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 SUN 0.5mg hard capsules 28
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- HAF2945A
- ExpiryOn the carton, blister or label.
- 30/11/2027
- First distributedOn the product, its label or its packaging.
- 08/05/2025
What to do now
A fault with the packaging or delivery device of Fingolimod SUN 0.5mg hard capsules has been found.
- 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.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
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
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/49). Quoted as issued.
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.
The risk
DMRC reference number DMRC - 37582999 Marketing Authorisation Holder
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.
Patients who have received Fingolimod SUN 0.5mg hard capsules from batch HAF2945A are advised to continue to take the capsules and, where possible, pierce the foil before removing the capsule. The capsule contents are not impacted by this issue. Patients who are experiencing capsules breaking upon removal from the blister should speak to their dispensing pharmacist in the first instance.
The recall is being actioned at the wholesaler and pharmacy levels.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
Patients who have received Fingolimod SUN 0.5mg hard capsules from batch HAF2945A are advised to continue to take the capsules and, where possible, pierce the foil before removing the capsule. The capsule contents are not impacted by this issue. Patients who are experiencing capsules breaking upon removal from the blister should speak to their dispensing pharmacist in the first instance.
The recall is being actioned at the wholesaler and pharmacy levels.
Patients who experience adverse reactions or have any questions about their 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 SUN 0.5mg hard capsules been recalled?
A fault with the packaging or delivery device of Fingolimod SUN 0.5mg hard capsules has been found. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
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?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.