MHRA Class 3 Medicines Recall: Fingolimod SUN 0.5mg hard capsules (Sun Pharmaceutical Industries Limited)
MHRA Class 3 Medicines Recall: Fingolimod SUN 0.5mg hard capsules (Sun Pharmaceutical Industries Limited)
Drug Alert Number: EL(25)A/49
Date issued: 20 November 2025
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.
DMRC reference number: DMRC – 37582999
Medicine Details
Fingolimod SUN 0.5mg hard capsules (PL: 31750/0173)
Active ingredient: fingolimod (as hydrochloride)
SNOMED code: 41496911000001109
GTIN: 8718531949683
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| HAF2945A | 30/11/2027 | 28 | 08/05/2025 |
Background
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.
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.
View full alert here.
Advice for Healthcare Professionals to Provide to 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.
Additional Information
For all medical information enquiries and information on this product, please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050 / 07974 754551.
For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050
