Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules recalled
Class 3 medicines recall: The MHRA has published a Class 3 medicines recall for Fingolimod SUN 0.5mg hard capsules.
Published: 20 November 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Class 3 medicines recall for Fingolimod SUN 0.5mg hard capsules. 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.
Pharmacists are advised to stop supplying the affected batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further information, advice and details of the affected batch can be found on the MHRA website.