FDA tells clinics to stop using one Yimmugo immune globulin lot
The FDA on Tuesday told hospitals and clinics to stop using Yimmugo lot C795314 after more reports of allergic reactions. Some patients needed epinephrine or a hospital stay. Yimmugo, made by Biotest AG, gives antibodies by IV to adults whose bodies make too few of their own.
The Food and Drug Administration has told health care facilities to stop using one lot of an antibody infusion after a rise in allergic reactions. The FDA's Oct. 6 notice names Yimmugo lot C795314, made by Biotest AG, with an expiration date of April 30, 2027.
The FDA's reporting system received more reports than expected of allergic reactions after infusions from this lot, the agency said. Some were serious. Patients needed epinephrine, steroids, or a trip to the emergency room or hospital. Allergic reactions are a known risk with these products, but the FDA said the higher reporting for this lot presents a heightened safety risk.
While it investigates, the FDA asks facilities to check their stock right away, stop using any vials from the lot, and contact the maker with questions.
Yimmugo is an immune globulin given through an IV. It supplies antibodies to adults with primary humoral immunodeficiency, a condition in which the body cannot make enough of its own antibodies to fight infections, Express Scripts notes.
This is not the first problem with the product. Biotest began a voluntary withdrawal of certain Yimmugo lots on Aug. 13 because of a higher rate of allergic reactions, including a small number that were medically significant, Express Scripts reported. In mid-August, the blood banking group AABB said two Yimmugo lots had been added to a list of withdrawn products, along with one lot each of Grifols' Gammaked and Gamunex-C.
The pattern goes back further. In October 2025, the FDA began looking into more allergic reaction reports tied to lots of two ADMA Biologics products, Asceniv and Bivigam, AABB reported. In each case, the FDA told facilities to check stock and stop using the affected lots.
Patients and providers can report suspected reactions to the FDA at 1-800-FDA-1088 or at fda.gov/medwatch.
What we know: The FDA has flagged lot C795314 and told facilities to stop using it.
What we don't: How many reactions were reported, and whether more lots will be named.
Where outlets agree The FDA and Express Scripts both say Yimmugo lots from Biotest have drawn higher rates of allergic reactions, some of them serious.
Where they differ The FDA notice gives no count of reactions and does not say whether lot C795314 is tied to the lots Biotest pulled in August.