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Medicines recallMHRA

Emylif 50mg orodispersible film recalled over an impurity

Impurity above limitsMedium riskClass 3

Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.

Check your product

Only products that match these details are covered. Have your pack in front of you.

3 identifiers listed for this notice.

  • Emylif 50mg orodispersible film 56 sachets

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • C24QA104
    ExpiryOn the carton, blister or label.
    • 04-2027
    First distributedOn the product, its label or its packaging.
    • 13/05/2025

What to do now

Affected batches of Emylif 50mg orodispersible film contain an impurity, such as a nitrosamine, above the accepted limit.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/47). Quoted as issued.

Summary

Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.

The risk

DMRC reference number DMRC - 35367036 Marketing Authorisation Holder

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.

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 .

Advice for 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 .

Open the MHRA notice

Questions

Why has Emylif 50mg orodispersible film been recalled?

Affected batches of Emylif 50mg orodispersible film contain an impurity, such as a nitrosamine, above the accepted limit. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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