Counterfeit cancer drug alert: The WHO has issued a medical product alert for two batches of falsified DARZALEX (daratumumab) — a monoclonal antibody used to treat multiple myeloma and AL amyloidosis — detected in Maldives and Mexico. The fake products, supplied by unauthorized distributors, have unknown contents and may be ineffective or harmful. Batch numbers MYS7381 and STV1K01 have been confirmed invalid by manufacturer Janssen.
The WHO has issued Medical Product Alert N°3/2026, warning of two batches of falsified DARZALEX (daratumumab) — a monoclonal antibody used to treat multiple myeloma and AL amyloidosis — detected in Maldives and Mexico. The incidents were reported to WHO in May and June 2026 by national regulatory authorities in both countries. In at least one case, hospitals received the falsified products from non-authorized distributors.
Manufacturer Janssen has confirmed that batch numbers MYS7381 and STV1K01 are not valid. One batch (STV1K01) was found to contain visible particulate matter, raising serious contamination concerns. The contents, sterility, and quality of these products remain unknown — they may lack active ingredients or contain harmful substances, putting patients at risk of treatment failure, disease progression, or adverse reactions.
Key Takeaways:
Why it matters: Patients with multiple myeloma and AL amyloidosis depend on DARZALEX as a critical therapy. Falsified versions not only deny them effective treatment but may actively cause harm — making rapid detection and supply chain vigilance essential.
