August 21, 2026
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On Aug. 12, 2026, Grifols Therapeutics initiated a voluntary withdrawal of one lot of Gamunex®-C (immune globulin injection [human], 10%), 40g/400mL vial. The withdrawal was conducted as a precautionary measure due to an increased rate of allergic or hypersensitivity-type reactions associated with these specific lots, a small number of which were considered medically significant. Hypersensitivity and anaphylactic or anaphylactoid reactions are a known risk with immune globulin products. Gamunex-C is FDA-approved for the treatment of PI, ITP and CIDP. For more information about the recall, see here.
Last updated: August 21, 2026