Gamunex-C Recalled

Grifols Therapeutics LLC issued a voluntary withdrawal of two lots of Gamunex-C^® (immune globulin injection [human], 10%) on Sept. 30, 2025, following a rise in reported hypersensitivity reactions associated with the affected vials. This marks the fourth such withdrawal in 2025, with previous actions taken on Feb. 19, Mar. 21 and Aug. 8, 2025, for the same safety concern. Gamunex-C is indicated for the treatment of primary humoral immunodeficiency (PI) in patients aged two years and older, idiopathic thrombocytopenic purpura (ITP) in both pediatric and adult populations and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. While hypersensitivity and anaphylactic reactions are already noted in the product’s prescribing information under warnings and precautions, the withdrawn lots may carry an elevated risk for these adverse events.