The WHO has issued an alert after discovering a falsified version of SIMULECT (basiliximab) for injection circulating in parts of Africa and Europe. The counterfeit product has been identified in Rwanda, Bulgaria, and Türkiye, following reports to WHO in December 2024 and November 2025.
SIMULECT is a monoclonal‑antibody immunosuppressant used to prevent acute organ rejection in children and adults undergoing kidney transplants. The falsified vials, however, contain no active pharmaceutical ingredient — forensic testing confirmed they hold only ascorbic acid.
The packaging of the counterfeit product reveals multiple inconsistencies: the batch number “SFYD2” does not match any valid SIMULECT batch; dosing is labelled in “MG” (capital letters) instead of “mg”; and the stated country of manufacture is ambiguously given as “Switzerland or France,” diverging from the genuine product’s labeling.
Use of the falsified SIMULECT carries serious health risks: patients may suffer therapeutic failure resulting in organ rejection, or experience inadequate or excessive immune suppression, increasing vulnerability to infections. There is also risk of toxic or allergic reactions from unknown ingredients, as well as possible infection from non‑sterile injection.
WHO has urged regulatory authorities, health‑care professionals, and the public to intensify vigilance across supply chains — especially in informal or unregulated markets and online platforms — and to report any suspected falsified SIMULECT. Health‑care providers are warned against using any SIMULECT with the suspect batch number, and anyone who may have received this medicine is advised to seek medical attention.
The organisation recommends obtaining all medical products only from licensed and authorized suppliers, and encourages anyone with information about the manufacture or supply of the falsified product to contact WHO via its designated rapid‑alert email.
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