MHRA Class 2 Medicines Recall: Mercaptopurine 50mg Tablets (Aspen Pharma Trading Limited)
MHRA Class 2 Medicines Notification: Mercaptopurine 50mg Tablets (Aspen Pharma Trading Limited)
Drug alert number: EL(25)A/23
Date issued: 22 May 2025
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.
DMRC reference number:DMRC-35559868
Company name: Aspen Pharma Trading Limited
Medicine Details
Product name: Mercaptopurine 50mg tablets (PL: 39699/0047)
Active ingredient: mercaptopurine
SNOMED code: 22519811000001102
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| P0010384 | 31/12/2028 | 25 | 08/01/2025 |
Background
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 contamination has been identified as Penicillium Kongii.
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.
View the full alert here.
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.
Additional information
For all medical information enquiries and information on this product, please email Aspenmedinfo@professionalinformation.co.uk or telephone 01748 828391
For stock control enquiries please email uk.stockenquiries@aspenpharma.eu
