Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
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 Number: DMRC - 37582999
Company name: Sun Pharmaceutical Industries Limited
Product description: Fingolimod SUN 0.5mg hard capsules
PL: 31750/0173
Active Ingredient: fingolimod (as hydrochloride)
SNOMED code: 41496911000001109
Details of the affected batch:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| HAF2945A | 30/11/2027 | 28 | 08/05/2025 |
Background information:
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 to 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 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
Company contacts for further 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.
To access the full recall/alert: