Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

October 28, 2025 

As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant. Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products. 

1. Please examine your stock immediately to determine if you have any vials from these lots. 
2. If you have product from these lots, please cease use immediately. 
3. Return the affected product to the point of purchase to receive replacement product. 

Product Lot	Date of Voluntary Withdrawal	Expiration Date	Manufacturer
Xembify Lot # B01J108133	10-Jan-2025	30-Oct-2027	Grifols
Xembify Lot # B01J107803	13-Jan-2025	29-Oct-2027	Grifols
Bivigam Lot # 321524	31-Jan-2025	31-Jul-2027	ADMA Biologics
Panzyga Lot #L319C8261	12-Feb-2025	14-May-2026	Octapharma
Gamunex-C Lot #B01J112733	19-Feb-2025	8-Nov-2027	Grifols
Bivigam Lot # 321724	27-Feb-2025	31-Aug-2027	ADMA Biologics
Bivigam Lot # 237447	20-Mar-2025	30-Jun-2027	ADMA Biologics
Gamunex-C Lot # B23K001433	21-Mar-2025	18-Dec-2027	Grifols
Gamunex-C Lot # B01J093362	08-Aug-2025	02-Dec-2027	Grifols
Gamunex-C Lot # B01J094362	08-Aug-2025	08-Dec-2027	Grifols
Gamunex-C Lot # B23K037203	29-Sep-2025	20-Mar-2028	Grifols
Gamunex-C Lot # B21K039363	29-Sep-2025	18-Mar-2028	Grifols
Gammaked lot # B03J086043	28-Oct-2025	31-Aug-2027	Grifols for Kedrion
Gamunex-C lot # B01J100623	28-Oct-2025	03-Oct-2027	Grifols
Gamunex-C lot # B03J077152	28-Oct-2025	10-Oct-2027	Grifols
Gamunex-C lot # B03J079503	28-Oct-2025	16-Aug-2027	Grifols
Alyglo Lot # 394C24030	16-Dec-2025	01-Oct-2027	GC Biopharma Corp.