FDA

Immune globulin products withdrawn over hypersensitivity concerns

March 12, 2025

Certain lots of IV and SC immune globulin products have been voluntarily withdrawn by manufacturers due to a higher incidence of allergic/hypersensitivity reactions, some of which were medically significant. Hypersensitivity and anaphylactic reactions are known risks with immune globulin products.

Affected products include the following:

• Bivigam: Lot #321524, exp date 7/31/2027; Lot #321724, exp date 8/31/2027
• Gamunex-C: Lot #B01J112733, exp date 11/8/2027
• Panzyga: Lot #L319C8261, exp date 5/14/2026
• Xembify: Lot #B01J108133, exp date 10/30/2027; Lot #B01J107803, exp date 10/29/2027

Clinicians are advised to immediately check their stock for these lots and cease use if found. Affected products should be returned to the point of purchase for replacement. Adverse reactions should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program.

Source:

(2025, March 10). FDA. Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/voluntary-lot-withdrawals-immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc-0