MHRA Class 2 Medicines Recall: Fingolimod Zentiva 0.5 mg Capsules (Zentiva Pharma UK Limited)
MHRA Class 2 Medicines Recall: Fingolimod Zentiva 0.5 mg Capsules (Zentiva Pharma UK Limited)
Drug alert number: EL(26)A/37
Date issued: 20 August 2026
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles.
DMRC reference number: DMRC-39754868
Company name: Zentiva Pharma UK Limited
Medicine Details
Fingolimod Zentiva 0.5 mg Capsules (PL: 17780/0858)
Active Ingredient: Fingolimod
SNOMED code: 40459211000001106
GTIN: 8594739260931
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| 4L01372H | 11/2027 | 28 | 28 January 2025 |
Background
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles. The particles, if present, are known to be small and pose a low risk to the safety or efficacy of the tablets. No reports have been received to date, the particles were identified during shelf-life testing.
Advice for Healthcare Professionals
Stop supplying the affected batches. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
View the alert here.
Advice for Healthcare Professionals to Provide to Patients
No further action is required by patients as this product is used by healthcare professionals and they will have taken the action to remove this product from use.
The recall is a precautionary measure to mitigate any additional risk of infection.
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 UKMedInfo@zentiva.com, or telephone 0800 090 2408.
For stock control enquiries please email ukcustomerservices@zentiva.com, or telephone 01371 822022.
