Gammaked Recalled

On Aug. 11, 2026, Grifols Therapeutics initiated a voluntary withdrawal of one lot of Gammaked^™ (immune globulin injection [human], 10%), 20g. The withdrawal was conducted as a precautionary measure due to an increased rate of allergic or hypersensitivity-type reactions associated with this specific lot, a small number of which were considered medically significant. Hypersensitivity and anaphylactic or anaphylactoid reactions are a known risk with immunoglobulin products. Gammaked is FDA-approved for the treatment of primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP). For more information about the recall, see here.