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Medicines recallMHRA

Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma recalled over an impurity

Impurity above limitsHigh riskClass 2

LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine 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.

  • Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma 10 x 10

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • D00993
    ExpiryOn the carton, blister or label.
    • 31/01/2026
    First distributedOn the product, its label or its packaging.
    • 13/07/2023

What to do now

An impurity has been found in Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma at a level above what is allowed.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA 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

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.

Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/38). Quoted as issued.

Summary

LEO Pharma is recalling the affected batch as a precautionary measure due to out of specification results for impurities during routine stability testing.

The risk

DMRC reference number DMRC-36306427 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

LEO Pharma can confirm 1,848 packs of this batch have been released and distributed. No related adverse event reports or product quality complaints have been received related to this defect.

No further action is required by patients as this is a Pharmacy and Wholesaler level recall related to a specific batch of Fucidin 250 mg Tablets.

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 related to a specific batch of Fucidin 250 mg Tablets.

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 Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma been recalled?

An impurity has been found in Fucidin 250 mg Tablets, LEO Laboratories Ltd trading as LEO Pharma at a level above what is allowed. 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?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

Related notices