Source: MHRA/Gov.uk 20.11.2025
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
Marketing Authorisation Holder
Sun Pharmaceutical Industries Limited
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.
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 / 07974754551.
For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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