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Medicine recalls and shortages › Recalls and defects › 22 May 2025
Medicines recall

Mercaptopurine 50mg tablets

Issued on 22 May 2025 · source: MHRA — Medicines and Healthcare products Regulatory Agency
Affected batches: P0010384 (31/12/2028)
Check the batch number on the pack. The medicine remains licensed; other batches are not affected.
Class 2 recall · DMRC-35559868 · PL: 39699/0047 · licence holder: Aspen Pharma Trading Limited · active ingredient: mercaptopurine · licence PL: 39699/0047

What this means

The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.

Class 2 recall · DMRC-35559868

ProductLicenceActive ingredientGTIN
Mercaptopurine 50mg tabletsPL: 39699/0047mercaptopurine05060598250817

Batches (expiry): P0010384 (31/12/2028)

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.

Tracked from information published by the MHRA and the NHSBSA. This information is for guidance only and does not replace advice from your doctor or pharmacist.