FDA Announces Voluntary Recall of IVIG, IGSC Due to Allergic Reaction Risk
March 12, 2025
The Food and Drug Administration issued a
safety and availability communication on Tuesday to alert the health care community to voluntary withdrawals of several lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) due to a higher rate of allergic/hypersensitivity type 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.