Sun Pharma recalls one batch of Fingolimod SUN 0.5mg hard capsules over capsules breaking in the blister
Reports say capsules in one batch of Fingolimod SUN 0.5mg hard capsules break when removed from the blister, though the notice says the capsule contents are not affected.
What to do
Healthcare professionals must stop supplying batch HAF2945A immediately, quarantine all remaining stock and return it to their supplier using the supplier's approved process. Patients who have this batch are advised to keep taking the capsules and, where possible, pierce the foil before removing the capsule. Patients whose capsules break should speak to their dispensing pharmacist first; for questions, email Cserv.uk@sunpharma.com or telephone 020 8848 5050.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Fingolimod SUN 0.5mg hard capsules
- Hazard
- 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.
- Identifiers
- DMRC reference number: DMRC - 37582999
- PL: 31750/0173
- Active Ingredient: fingolimod (as hydrochloride)
- SNOMED code: 41496911000001109
- GTIN: 8718531949683
- MHRA reference: EL(25)A/49
- Issued
- November 20, 2025
- Published on GOV.UK
- November 20, 2025
- Listed on Recalled Today
- November 20, 2025
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from MHRA.
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
- 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 DMRC@mhra.gov.uk
- Download document
- Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
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