A batch of the chemotherapy drug mercaptopurine, widely used in treating certain forms of leukaemia, has been recalled following reports of microbial contamination. Health authorities are advising patients to inspect their medication for discolouration and consult healthcare professionals if affected tablets are found.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a safety alert after healthcare workers noticed some tablets from a specific batch exhibited an unusual colour change. This precautionary recall is designed to prevent any potential health risks associated with the contamination.
Details of the Recall and Contamination Concerns
According to the MHRA, the affected batch of mercaptopurine 50mg tablets carries the batch code P0010384 and was initially distributed in January 2025. The tablets, which should be pale yellow and marked with “PT / 50,” were found to have discolouration linked to contamination by the fungus Penicillium kongii.
Aspen Pharma Trading Limited is conducting the recall following a small number of complaints from healthcare professionals who identified the discoloured tablets upon opening the packs.
The MHRA emphasised that patients should not discontinue their treatment without consulting their specialist or prescriber, as stopping chemotherapy abruptly may jeopardise treatment outcomes.
Patients and carers are urged to check their medication packaging carefully. Any tablets showing discolouration from this specific batch should prompt immediate contact with a relevant healthcare provider for guidance on next steps.
Mercaptopurine’s Role in Leukaemia Treatment and Usage Guidance
Mercaptopurine is a chemotherapy agent that works by interfering with the DNA synthesis and repair mechanisms in cancer cells, thereby limiting their ability to grow and multiply. It is primarily prescribed for the treatment of acute lymphoblastic leukaemia (ALL) and other related blood cancers.
The medication can be taken with or without food but should not be consumed alongside milk or dairy products such as yoghurt and cheese, as these may reduce the drug’s effectiveness. Patients must adhere strictly to their prescribed regimen and seek advice if any issues arise.
The recall underscores the ongoing challenges in ensuring drug safety and the critical role regulatory bodies play in protecting patients. Health professionals continue to monitor such cases closely to maintain trust in essential cancer therapies and to prevent contamination risks in pharmaceutical manufacturing.