Falsified Medical Product Alert N°3/2026
DARZALEX (daratumumab) injection: falsified product alert
WHO issued this alert on two falsified batches of DARZALEX reported by the national regulators of the Maldives and Mexico in May and June 2026. The products were supplied or offered by non-authorised distributors and in at least one case reached hospitals. The Maldives Food and Drug Authority reported visible particulate matter in vials of batch STV1K01. No laboratory testing had been conducted.1,2
- Issued
- 3 July 2026
- Issued by
- World Health Organization
- Name stated on packaging
- Packaging bears the DARZALEX brand of Janssen with batch numbers that Janssen says are not valid.
- Genuine manufacturer's statement
- WHO said the genuine manufacturer, Janssen, confirmed the batch numbers are not valid and that any DARZALEX with these batch numbers should be considered falsified.
- Countries where detected
- Maldives, Mexico
Batches named in the alert
Listed in the annex to the WHO alert: check the annex linked in the sources
Advice as stated
Do not use these products. Obtain medicines only from authorised suppliers. Report adverse events or quality defects to the national regulator or WHO.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°3/2026: Falsified DARZALEX (daratumumab) (3 July 2026)
- World Health Organization, Medical Product Alert N°3/2026: annex (PDF) (3 July 2026)