Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 Mg Hard Capsules, El(26)a/02

Recall Summary Glenmark Pharmaceuticals Europe Limited is recalling one batch of Fingolimod Glenmark 0.5 mg capsules distributed in the United Kingdom because stability testing found the capsules dissolve slower than they should. This recall affects patients in the United Kingdom who have this medication.

Recalling firm
Glenmark Pharmaceuticals Europe Limited
Reason
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.
Classification
Class II
Category
drug recall
Country
United Kingdom
Agency
UK Medicines and Healthcare products Regulatory Agency
Recall date
2026-01-21
Status
Ongoing
Distribution
United Kingdom

Official recall notice from UK Medicines and Healthcare products Regulatory Agency

Recall details on Nibble Recalls: https://trynibble.app/recalls/273ddb46-432f-44f7-ba76-94245629a540