FDA Identified IGIV Lot Linked to Hypersensitivity Reactions
The FDA is investigating reports of severe reactions in patients who received a specific lot of immune globulin.
Updated on Oct. 6, 2026 in Allergies
The FDA identified a specific lot of Immune Globulin Intravenous (IGIV) associated with an increased number of hypersensitivity reactions. Patients across the United States have reported adverse events requiring urgent medical care, including hospitalizations.
Why it matters
Identifying these clusters is critical for patient safety, as hypersensitivity reactions to IGIV can be severe and require immediate medical intervention. This investigation helps clinicians and patients recognize potential risks associated with specific product batches.
Data from the FDA Adverse Event Reporting System identified elevated hypersensitivity events linked to a single IGIV lot. The findings are based on patient and provider reports of reactions, some of which necessitated the use of epinephrine or steroid treatments.
The players
FDA
The federal agency responsible for regulating medical products and monitoring public health through adverse event surveillance.
The details
Immune globulin products are derived from human plasma and are typically used to treat various immune-related conditions. While hypersensitivity and anaphylactic reactions are known potential risks of IGIV therapy, this investigation focuses on a specific lot showing a higher-than-expected rate of complications. These reactions can occur during or after infusion, triggering immune responses that require emergency medical support, such as hospital admission or specialized medication.
Timeline
The FDA issued a safety notification regarding the specific IGIV lot on October 6, 2026.
Health Landscape
This alert is part of the ongoing safety monitoring conducted through the FDA Adverse Event Reporting System. It highlights the importance of batch-specific tracking for biologic therapies, which are essential to the modern treatment of complex immune disorders.
Patients who receive IGIV therapy should discuss any new or worsening symptoms with their healthcare provider immediately. If you experience signs of a reaction after an infusion, seek emergency medical care and report the event by calling 1-800-FDA-1088.
The takeaway
While hypersensitivity is a known risk for immune globulin, these increased reports warrant extra vigilance during and after infusion treatments. Patients should keep a record of their treatment lots and consult their physician about any concerns regarding safety alerts.
Further reading
For more on managing immune-related sensitivities, see our Allergies section.
More information
To report a suspected adverse event or review safety guidelines, visit the FDA adverse event reporting portal.
