August 22, 2025
The Food and Drug Administration updated its safety and availability communication on the voluntary recall of immune globulin intravenous (IVIG) and immune globulin subcutaneous (IGSC) to include two additional lots. The recall follows reports of increased rates of allergic and hypersensitivity reactions.
The agency recommended that staff at facilities immediately examine their stock to determine if they have vials from these lots and, if so, cease use immediately. Facilities may return affected products to the point of purchase to receive replacement products.
Members with questions may contact AABB Regulatory Affairs at regulatory@aabb.org.