Falsified Medical Product Alert N°6/2025
SIMULECT (basiliximab) for injection: falsified product alert
WHO issued this alert on falsified SIMULECT, an immunosuppressant used to prevent kidney transplant rejection, reported to WHO in December 2024 and November 2025. WHO said any SIMULECT product with batch number SFYD2 should be considered falsified. Listed risks include organ rejection and infection from unsterile injections.1
- Issued
- 9 December 2025
- Issued by
- World Health Organization
- Name stated on packaging
- Falsified labels show NDC 0078-0331-84, the unit MG instead of mg, and the wording Product of Switzerland or France instead of the genuine Product of France.
- Genuine manufacturer's statement
- WHO said the genuine manufacturer forensically tested a sample and found no active pharmaceutical ingredient. It contained ascorbic acid instead.
- Countries where detected
- Rwanda, Bulgaria, Türkiye
Batches named in the alert
SFYD2
Advice as stated
Do not use the listed products. Obtain medicines only from authorised or licensed suppliers. Report adverse events, lack of effect or suspected falsification to the national regulatory authority or pharmacovigilance centre.
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°6/2025: Falsified SIMULECT (basiliximab) for injection (9 December 2025)