Gammaked Recalled

On Nov. 6, 2025, Grifols Therapeutics initiated a voluntary recall of one lot of Gammaked® (immune globulin injection [human]). The recall was prompted by an increased rate of allergic and hypersensitivity type reactions associated with the affected lot, including a small number of medically significant cases. Gammaked is FDA-approved for the treatment of primary humoral immunodeficiency, idiopathic thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy and Kawasaki disease. Hypersensitivity and anaphylactic/anaphylactoid reactions are known risks associated with immune globulin products.