Urgent recall of Mercaptopurine tablets after deadly fungal contamination threatens patient safety

An urgent medicine recall has sent shockwaves through the UK healthcare system as a batch of cancer treatment tablets has been found contaminated with a dangerous fungus. Aspen Pharma Trading Limited has issued a Class 2 Medicines Recall for a specific batch of Mercaptopurine 50mg tablets, raising serious concerns over patient safety and potential health risks.

The recall, prompted by reports of discoloured tablets, targets batch number P0010384, with an expiry date of 31 December 2028. The affected packs, each containing 25 tablets, were first distributed in January 2025, meaning some patients may have been exposed for several months.

Mercaptopurine is a crucial chemotherapy drug widely used in treating cancers such as leukaemia. The discovery of microbial contamination, specifically by Penicillium kongii — a fungal species not typically associated with medication — has forced healthcare professionals to act swiftly.

Healthcare workers first noticed the issue when opening packs and observing unusual discolouration on the tablets. Following this, an investigation confirmed fungal contamination, prompting Aspen Pharma to immediately halt distribution of the affected batch.

The Medicines and Healthcare products Regulatory Agency (MHRA) swiftly stepped in to oversee the recall and provide guidance to healthcare providers. Professionals have been instructed to cease dispensing the compromised batch immediately, quarantine any remaining stock, and return it to suppliers via established procedures.

Patients currently prescribed Mercaptopurine are urged to check their medication carefully. Those who notice any abnormalities, particularly discolouration, should contact their healthcare provider without delay. The product is identifiable by its Global Trade Item Number (GTIN) 05060598250817 and is marketed under licence PL: 39699/0047 by Aspen Pharma Trading Limited.

This recall acts as a precaution to avoid any potential risk of infection or adverse reactions caused by the fungal contamination. Experts warn that fungal exposure in immunocompromised patients, such as those undergoing chemotherapy, could lead to serious health complications.

JD Vance, Vice President of Aspen Pharma, stated the recall is a priority to ensure patient safety and confidence in the drug supply. The company continues to collaborate closely with regulatory bodies to resolve the issue and prevent future occurrences.

Medical professionals or patients seeking further information can reach out directly to Aspen Pharma’s dedicated medical information team via email at [email protected] or telephone 01748 828391.

This incident has reignited debates about the safety and sterility of pharmaceutical manufacturing processes. While contamination is rare, this episode highlights the importance of rigorous quality control and prompt action when risks are detected.

Mercaptopurine’s role in cancer treatment cannot be overstated; it remains a vital component of many chemotherapy regimens. The swift recall by Aspen Pharma aims to protect vulnerable patients and maintain trust in essential medicines.

As investigations continue, the healthcare sector and patients alike remain on high alert. Those prescribed Mercaptopurine are advised to monitor their medication carefully, heed recall instructions, and consult healthcare professionals if they suspect any issues.

The MHRA continues to monitor the situation closely, ensuring all necessary measures are taken to safeguard public health. This recall serves as a stark reminder of the delicate balance between lifesaving treatments and the stringent standards required in pharmaceutical production.