The World Health Organization has issued a global warning over falsified batches of DARZALEX (daratumumab), a critical medicine used to treat serious blood cancers and rare bone marrow disorders, after counterfeit products were discovered in the Maldives and Mexico.

 

WHO’s Medical Product Alert N°3/2026 concerns two falsified batches of DARZALEX injection — MYS7381 and STV1K01 — which were supplied or offered through unauthorized distributors. In at least one reported case, hospitals received the counterfeit medicine.

 

The incidents were reported to WHO by national regulatory authorities in the Maldives and Mexico in May and June 2026.

 

DARZALEX, a monoclonal antibody medicine, is used in the treatment of multiple myeloma and amyloid light-chain (AL) amyloidosis, conditions that affect bone marrow and can be life-threatening.

 

WHO said the products are considered falsified because they deliberately misrepresent their identity, composition, or source. The genuine manufacturer, Janssen Pharmaceuticals, confirmed that the batch numbers appearing on the counterfeit products are not genuine.

 

“Any DARZALEX product with these batch numbers should be considered falsified and not used,” WHO warned.

 

The Maldives Food and Drug Authority also reported visible particulate matter inside vials from falsified DARZALEX bearing batch number STV1K01, raising concerns over possible contamination.

 

WHO warned that the counterfeit medicine has not undergone laboratory testing, meaning its contents, quality, and sterility cannot be verified.

 

The falsified products may contain no active ingredient, incorrect ingredients, or potentially harmful substances, making them ineffective or dangerous for patients.

 

The presence of visible particles in at least one batch indicates a possible contamination risk, which could lead to infections, adverse reactions, or complications linked to injections.

 

Patients who receive counterfeit DARZALEX may also fail to receive effective treatment, allowing their disease to worsen and increasing the risk of serious health outcomes, including increased illness and death.

 

WHO said rapid identification and removal of the products from the supply chain is essential to protect patients.