FDA Investigating Hypersensitivity Reports Tied to IGIV Lot

The Food and Drug Administration is investigating increased reports of allergic and hypersensitivity reactions following infusion of a specific lot of intravenous immune globulin (IGIV). The affected product is Yimmugo (Biotest AG), lot C795314, which expires April 30, 2027.

Some reported reactions were severe and required treatment with epinephrine or steroids, an emergency room visit or hospitalization. FDA noted that hypersensitivity reactions are a known risk of immune globulin products but said the increased reporting associated with this lot presents a heightened safety risk.

While the investigation continues, FDA recommends that facilities immediately check their stock and stop using any vials from the affected lot. Facilities with questions should contact the manufacturer.

Suspected adverse events can be reported through FDA’s MedWatch program.