Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
August 14, 2026
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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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.
- Please examine your stock immediately to determine if you have any vials from these lots.
- If you have product from these lots, please cease use immediately.
- 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. |
| Gammaked Lot # B13K127733 | 11-Aug-2026 | 19-Oct-2028 | Grifols |
| Gamunex-C Lot # B23L053203 | 11-Aug-2026 | 30-Apr-2029 | Grifols |
| Yimmugo Lot # C795145 | 13-Aug-2026 | 31-Oct-2027 | Biotest AG |
| Yimmugo Lot # C795165 | 13-Aug-2026 | 30-Sep-2027 | Biotest AG |