Skip to navigation Skip to main content Skip to footer

Recalls and Alerts

Update Type 2

Class 3 Recall

22.01.2026

Class 3 recall- Fingolimod Glenmark 0.5 mg Hard Capsules

CLASS 3 RECALL

 

PLEASE READ AND CONFIRM THAT YOU HAVE RECEIVED THIS.

 

We have received a Class 3 Recall from Glenmark Pharmaceuticals Europe Limited on FINGOLIMOD CAP 0.5MG

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-limited-fingolimod-glenmark-0-dot-5-mg-hard-capsules-el-26-a-slash-02?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=53be9484-a57c-41df-9fe0-10338d61497b&utm_content=immediately

 

MHRA ref: DMRC-38142990

 

Reason: 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.

 

Pip codeProduct descriptionSupplierBatch Number
8082026FINGOLIMOD CAP 0.5MG 28 Amarox1501919
1251271FINGOLIMOD CAP 0.5MG ACC 28  Accord
1252311FINGOLIMOD CAP 0.5MG MYL 28 Viatris 
1254150FINGOLIMOD CAP 500MCG DRR 28Dr Reddy's
1263425FINGOLIMOD HARD CAP 500MCG SUN 28 SUN

Please can you ensure that your stores quarantine the product listed below.

 

Further Information

For all medical information enquiries and information on this product, medical_information@glenmarkpharma.com or telephone 0044 8004 580 383

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

 

Please return all affected stock to your original supplier for credit. As Alliance Healthcare has not supplied the affected batch, we will not be accepting returns.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.