Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions
October 28, 2025
The FDA Adverse Event Reporting System (FAERS) has received increased reporting of allergic/hypersensitivity type reactions following infusion of specific lots of Immune Globulin Intravenous (IGIV) and/or and Immune Globulin Subcutaneous (IGSC) listed below. Reports included serious adverse events, some of which were considered severe, requiring treatment with epinephrine, steroids, and/or admission to the emergency room or hospital. Though hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products, the increased reporting of hypersensitivity reactions to these lots presents heightened safety risks for patients.
While FDA investigates this safety issue, the Agency recommends the following:
- 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.
- If you have questions about a lot, please contact the manufacturer.
| Product Lot | Expiration Date | Manufacturer |
|---|---|---|
| Asceniv lot # 239825 | 31-Aug-2027 | ADMA Biologics |
| Bivigam lot # 237452 | 31-Oct-2027 | ADMA Biologics |
Continuous monitoring and assessment of the safety of all biological products, including IGIV and/or IGSC products, is an FDA priority and we remain committed to informing the public when we learn new information about these products. To report suspected adverse events, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.