FDA Compiles Recall List of 21 Immune Globulin Lots Following Rise in Hypersensitivity Reports

Immune globulin is a blood product relied upon by many patients with immunodeficiencies, neurological disorders, and autoimmune diseases. When a specific lot is associated with a higher-than-expected rate of hypersensitivity reactions, the impact extends beyond drug inventory to whether treatment can continue safely. On August 14, the U.S. Food and Drug Administration (FDA) published a consolidated list of intravenous and subcutaneous immune globulin lots voluntarily withdrawn by manufacturers following increased reports of allergic or hypersensitivity reactions.

The list covers 21 lots across seven branded products, with withdrawals spanning from January 2025 through August 2026. The latest additions are one lot each of Gammaked and Gamunex-C withdrawn on August 11, and two lots of Yimmugo withdrawn on August 13. The FDA said some reports were medically significant, but it did not disclose the number of patients, the distribution of reaction types, whether hospitalization was required, or the reporting rate for each lot. The magnitude of the increased risk therefore cannot currently be determined from the notice.

The FDA instructed healthcare facilities and suppliers to inspect their inventory immediately, stop using the listed lots, and return them to the original place of purchase for replacement. The notice applies to specific lot numbers, not entire brands or all immune globulin products. Whether patients need treatment adjustments should still be determined by their healthcare teams based on available inventory and individual clinical circumstances.

The alert also highlights an important distinction: hypersensitivity reactions and anaphylactic shock are already known risks of immune globulin products, but a known risk does not mean that unusual signals between lots can be disregarded. The FDA consolidated withdrawal information across manufacturers and brands so that facilities that may still hold older inventory can check each lot number individually.

A previous manufacturer notice from Grifols concerning Gamunex-C provides a more complete timeline. The company said that after receiving reports of allergic or hypersensitivity reactions through its pharmacovigilance system over the course of 2025, it withdrew 10 U.S. lots as a precaution. The action was taken with the knowledge of the FDA’s Center for Biologics Evaluation and Research. The manufacturer likewise instructed customers to stop using the affected lots immediately and return them through authorized distributors.

Gamunex-C may be used for primary humoral immunodeficiency, immune thrombocytopenia, and chronic inflammatory demyelinating polyneuropathy. Its safety information already warns of the possibility of severe hypersensitivity reactions. This also means that the practical handling of the lot withdrawals must balance safety with continuity of care; stopping use of affected lots should not be reduced to patients discontinuing immune globulin treatment on their own.

Key gaps remain in the current notice: neither the FDA nor the manufacturers have explained whether they identified a shared manufacturing, storage and transportation, or quality-related factor, and they have not provided background reporting rates for unaffected lots. What can currently be confirmed is a precautionary measure at the lot level, rather than a change in the overall benefit-risk assessment of immune globulin. Future investigation results may clarify whether these reactions share a common cause.