Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall for Fingolimod Zentiva 0.5 mg Capsules, marketed by Zentiva Pharma UK Limited.
A batch of the capsule (BN 4L01372H), first distributed on 28 January 2025, is being recalled as a precautionary measure due to a potential risk of contamination with metal particles.
The regulator said the particles were identified during shelf-life testing, and pose a low risk to the safety or efficacy of the capsules.
The healthcare professionals have been advised to stop supplying the affected batches, and quarantine all remaining stock and return it to the supplier.
NHS regional teams have been told to alert community pharmacists and dispensing general practitioners in this regard.
If patients have the affected batch they should contact their pharmacy, but they should not stop taking the medication without consulting healthcare professionals.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention.
