Class 3 Medicines Recall: Zambon Spa, Emylif 50mg Orodispersible Film, El(25)a/47

Recall Summary Zambon SpA is recalling a batch of Emylif 50mg orodispersible film (a medication) distributed in the United Kingdom because stability testing found unknown impurities at levels that don't meet specifications. This is a precautionary recall to prevent potential issues from the affected batch reaching patients.

Recalling firm
Zambon SpA
Reason
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
Classification
Class II
Category
drug recall
Country
United Kingdom
Agency
UK Medicines and Healthcare products Regulatory Agency
Recall date
2025-11-10
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/47bf417c-b1ea-4b84-9f29-41399e385341