MHRA Class 3 Medicines Recall: Emylif 50mg orodispersible film (Zambon SpA)
MHRA Class 3 Medicines Recall: Emylif 50mg orodispersible film (Zambon SpA)
Drug Alert Number: EL(25)A/47
Date issued: 10 November 2025
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
DMRC reference number: DMRC – 35367036
Medicine Details
Product name: Emylif 50mg orodispersible film (PL: 31654/0013)
Active ingredient: riluzole
SNOMED code: 42121311000001106
GTIN: 8031609001824
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| C24QA104 | 04-2027 | 56 sachets | 13/05/2025 |
Background
Ongoing stability testing identified out of specification results for unknown impurities at the 24-month stability timepoint for one batch of Emylif films. Emylif films were previously licensed with a 36-month shelf life.
The batch of Emylif 50mg orodispersible film specified in the table is being recalled as a precautionary measure before it reaches 24 months since the date of manufacture (C24QA104 would reach the 24-month timepoint on 30 April 2026).
Out of an abundance of caution, subsequent batches of Emylif 50mg orodispersible film, are labelled with an 18-month shelf life.
This recall is at pharmacy and wholesaler level.
Advice for healthcare professionals
Stop supplying the specified batch immediately. Quarantine all stock from this batch and return it to your supplier using your supplier’s approved process. The batch is being recalled at pharmacy and wholesaler level early as a precautionary measure. Other batches are not affected and may be supplied as per the printed expiry date.
View full alert here.
Advice for Healthcare Professionals to Provide to Patients
No further action is required by patients as this is a pharmacy and wholesaler level recall. Patients should continue to take medicines from batch C24QA104 as prescribed by the healthcare professional. This batch will remain within specification limits until 30 April 2026.
Patients who experience adverse reactions or have any questions about the 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 infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.
For stock control enquiries please email infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.
