MHRA Class 3 Medicines Recall: Fingolimod Glenmark 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd)

MHRA Class 3 Medicines Recall: Fingolimod Glenmark 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd)

Drug Alert Number: EL(26)A/02

Date issued: 21 January 2026

Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.

DMRC reference number: DMRC – 38142990

Marketing Authorisation Holder: Glenmark Pharmaceuticals Europe Limited

Medicine Details

Prednisolone 5mg Soluble Tablets PL: 25258/0323

Active ingredient:fingolimod hydrochloride

SNOMED code: 41463711000001102

GTIN: 05060204167041

Affected Lot Batch Numbers:

Background

Glenmark Pharmaceuticals Europe Limited is recalling the above batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.

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.

View full alert here.

Advice for Healthcare Professionals to Provide to Patients

No further action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

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 medical information enquiries please email medical_information@glenmarkpharma.com   or telephone +44 8004 580 383

For stock control enquiries please email orders.uk@glenmarkpharma.com.

The post MHRA Class 3 Medicines Recall: Fingolimod Glenmark 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd) appeared first on Community Pharmacy England.