Zambon recalls one batch of Emylif 50mg orodispersible film over out-of-specification test results
Stability testing of one batch of Emylif films found out of specification results for unknown impurities at 24 months, so the batch is recalled early as a precaution at pharmacy and wholesaler level.
What to do
Pharmacies and wholesalers must stop supplying batch C24QA104 immediately, quarantine all stock from it and return it to their supplier using the supplier's approved process. Patients need take no further action and should keep taking their medicine as prescribed. For enquiries, email infoUK@zambongroup.com or telephone + 44 (0)800 0288 942.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Emylif 50mg orodispersible film
- Company
- Zambon SpA
- Hazard
- Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.
- Identifiers
- DMRC reference number: DMRC - 35367036
- PL: 31654/0013
- Active Ingredient: riluzole
- SNOMED code: 42121311000001106
- GTIN: 8031609001824
- MHRA reference: EL(25)A/47
- Issued
- November 10, 2025
- Published on GOV.UK
- November 10, 2025
- Listed on Recalled Today
- November 10, 2025
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from MHRA.
Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
- DMRC reference number
- DMRC - 35367036
- Marketing Authorisation Holder
- Zambon SpA
- Medicine Details
- 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.
- 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. Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. Yours faithfully Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU Telephone +44 (0)20 3080 6574 DMRC@mhra.gov.uk
- Download document
- Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
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