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Medicines recallMHRA

Urospir 50mg/5ml Oral Solution recalled over a strength or dose problem

Wrong strength or doseMedium riskClass 3

Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in the SmPC and PIL.

Check your product

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

3 identifiers listed for this notice.

  • Urospir 50mg/5ml Oral Solution 150ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 1014870
    ExpiryOn the carton, blister or label.
    • 30/09/2025
    First distributedOn the product, its label or its packaging.
    • 29/11/2024

What to do now

Some batches of Urospir 50mg/5ml Oral Solution may not contain the right amount of active ingredient.

  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. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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/14). Quoted as issued.

Summary

Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in the SmPC and PIL.

The risk

DMRC reference number DMRC-35150350 Marketing Authorisation Holder

Advice for healthcare professionals

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

For products that have already been dispensed to patients and where prescribers have used the Rosemont SmPC for dose considerations by volume; these prescriptions should be reviewed.

This should only impact prescriptions where the volume (ml) has been written on the prescription, which could have led to an error in dose. e.g. incorrectly written as 100mg daily (20ml), whereas it should state 100mg daily (10ml).

Prescribers (GPs, Independent Prescribers Nurse Prescribers and all other relevant prescribers) should ensure that the correct dose had been requested.

This impacts patients that have been prescribed spironolactone oral solution from 29/11/2024 to 31/03/2025.

Should there be concern that a patient has been given a higher than required dose, the physician should review the case and contact the patient where appropriate.

Pharmacists who receive queries from patients should consider checking with the prescriber, where appropriate, to ensure that correct dose has been prescribed.

Details of the errors in the SmPC have been outlined in Appendix 1 of the download document (incorrect doses marked in strikethrough, correct doses highlighted in yellow, bold and underlined).

Patients who are taking Urospir 50mg/5ml Oral Solution (spironolactone) should continue to take the medication. Patients concerned about their dose, or are experiencing any of the side effects in Appendix 2 of the download document should contact their GP or pharmacist, who can check the correct dose and can provide advice on side effects.

Any suspected adverse reactions should also be reported online via the Yellow Card scheme or via the Yellow card app available from the Apple App Store or Google Play Store.

Advice for patients

Patients who are taking Urospir 50mg/5ml Oral Solution (spironolactone) should continue to take the medication. Patients concerned about their dose, or are experiencing any of the side effects in Appendix 2 of the download document should contact their GP or pharmacist, who can check the correct dose and can provide advice on side effects.

Any suspected adverse reactions should also be reported online via the Yellow Card scheme or via the Yellow card app available from the Apple App Store or Google Play Store.

Open the MHRA notice

Questions

Why has Urospir 50mg/5ml Oral Solution been recalled?

Some batches of Urospir 50mg/5ml Oral Solution may not contain the right amount of active ingredient. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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.

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