Medicines recallMHRA
Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited recalled over possible contamination
Aspen Pharma Trading Limited is recalling a specific batch of Mercaptopurine 50mg tablets as a precautionary measure due to microbial contamination following a small number of complaints of discoloured tablets within the packs, identified when the packs have been opened by healthcare professionals.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited 25
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- P0010384
- ExpiryOn the carton, blister or label.
- 31/12/2028
- First distributedOn the product, its label or its packaging.
- 08/01/2025
What to do now
Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited has been recalled because the product may not be as clean or sterile as it should be.
- 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.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.
Symptoms and when to get help
Look out for
- redness, swelling or pain where the product was used
- a high temperature
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
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/23). Quoted as issued.
Summary
Aspen Pharma Trading Limited is recalling a specific batch of Mercaptopurine 50mg tablets as a precautionary measure due to microbial contamination following a small number of complaints of discoloured tablets within the packs, identified when the packs have been opened by healthcare professionals.
The risk
DMRC reference number DMRC-35559868 Marketing Authorisation Holder
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Patients or carers should check to see if they have received tablets from the listed batch of Mercaptopurine 50 mg tablets (Batch P0010384). The batch number can be found on the label of the medicine bottle.
The tablets should be a ‘pale yellow colour and are marked with ‘PT / 50’, as per the Patient Information Leaflet (PIL). If you have tablets that are discoloured in any way, from the affected batch please contact your relevant healthcare professional responsible for your treatment, e.g. specialist or prescriber.
Patients should not stop taking their medication without discussing this with their specialist or prescriber as there may be a need for additional monitoring.
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
Patients or carers should check to see if they have received tablets from the listed batch of Mercaptopurine 50 mg tablets (Batch P0010384). The batch number can be found on the label of the medicine bottle.
The tablets should be a ‘pale yellow colour and are marked with ‘PT / 50’, as per the Patient Information Leaflet (PIL). If you have tablets that are discoloured in any way, from the affected batch please contact your relevant healthcare professional responsible for your treatment, e.g. specialist or prescriber.
Patients should not stop taking their medication without discussing this with their specialist or prescriber as there may be a need for additional monitoring.
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 Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited been recalled?
Mercaptopurine 50mg Tablets, Aspen Pharma Trading Limited has been recalled because the product may not be as clean or sterile as it should be. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.
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?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.