Fingolimod Zentiva 0.5mg capsules, Class 2 recall of batch 4L01372H

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 2 Medicines Recall on 20 August 2026, reference EL(26)A/37, for one batch of Fingolimod Zentiva 0.5 mg capsules. The marketing authorisation holder is Zentiva Pharma UK Limited. The notice is marked for distribution at pharmacy and wholesaler level.

The affected batch

The recall covers batch 4L01372H, expiry 11/2027, pack size 28, first distributed on 28 January 2025. The product licence number is PL 17780/0858. The notice gives the SNOMED code as 40459211000001106 and the GTIN as 8594739260931.

Zentiva is recalling the batch as a precautionary measure because of a potential risk of contamination with metal particles. The notice says the particles, if present, are known to be small and pose a low risk to the safety or efficacy of the capsules. It says no reports have been received and that the particles were identified during shelf-life testing.

What the notice asks of pharmacies

The notice is headed "Action within 48 hours". Its advice for healthcare professionals is to stop supplying the affected batch, quarantine all remaining stock and return it to the supplier using the supplier's approved process.

For patients, the notice advises that anyone holding the affected batch should contact their pharmacy in the first instance and should not stop taking the medication without speaking to a healthcare professional first. It says patients with this batch are not considered at risk. Suspected adverse reactions should be reported through the MHRA Yellow Card scheme.

What Class 2 means here

The MHRA's classification table puts a Class 2 recall where the defect may cause mistreatment or harm to the patient but is not life-threatening or serious. That places it between a National Patient Safety Alert, used where a defect presents a risk of death or disability, and a Class 3 recall, where harm is unlikely. The timing for this one is in the notice's own heading, action within 48 hours, and it asks NHS regional teams to forward it to community pharmacists and dispensing general practitioners.

Zentiva's medical information and stock control contacts are on the notice.

The full recall is on GOV.UK.