FDA Identified IGIV Lot Linked to Hypersensitivity
The agency is investigating reports of severe reactions linked to a specific lot of intravenous immune globulin.
Updated on Oct. 6, 2026 in Allergies
The FDA has identified a specific lot of Immune Globulin Intravenous (IGIV) associated with an increase in hypersensitivity reactions. Some patients required emergency room visits or hospitalization after receiving the product.
Why it matters
Heightened safety monitoring is essential because hypersensitivity and anaphylactic reactions are known, serious risks of immune globulin therapy. Identifying specific lots with elevated reporting rates helps protect patients from preventable adverse events.
The FDA Adverse Event Reporting System recorded an uptick in reactions requiring steroid or epinephrine treatment. The investigation into the safety profile of this specific lot remains ongoing.
The players
Food and Drug Administration
This federal agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs and biological products.
The details
Reported adverse events following IGIV infusion range from standard reactions to severe cases requiring professional medical intervention. Patients and healthcare providers are encouraged to report any suspected reactions to the FDA via phone or the agency's online portal.
Timeline
October 6, 2026: The FDA issued a safety notification regarding a specific IGIV lot.
The Big Picture
This action follows the operational procedures of the FDA Adverse Event Reporting System, which provides a critical framework for identifying potential pharmaceutical batch defects. The investigation aligns with established protocols for monitoring the safety of biological products in the United States.
Patients who have recently received IGIV should monitor their health for signs of hypersensitivity and seek immediate medical care if they experience severe symptoms. Those wishing to report adverse reactions can contact the agency at 1-800-FDA-1088.
The takeaway
Patients undergoing immune globulin therapy should remain vigilant for signs of hypersensitivity following an infusion. Always consult your healthcare provider if you have concerns about the safety of a specific medication lot.
Further reading
Learn more about managing treatment reactions in our Allergies section.
More information
To report a suspected reaction, visit the FDA adverse event reporting portal.
