Published: 7 October 2026 | FDA alert: 6 October 2026
At a Glance
- FDA has reported increased allergic/hypersensitivity reactions associated with Yimmugo IGIV lot C795314.
- Expiration date: 30 April 2027.
- Manufacturer: Biotest AG.
- Some reported events were serious and required epinephrine, steroids and/or emergency or hospital care.
- FDA recommends checking stock immediately and ceasing use of the affected lot while the investigation continues.
What healthcare facilities should do
- Check pharmacy and blood-product inventory for lot C795314.
- Segregate and stop use of affected vials.
- Inform pharmacy, transfusion/infusion teams and relevant clinical departments.
- Follow manufacturer and regulator instructions for affected stock.
- Report suspected adverse events through the appropriate pharmacovigilance system.
Clinical context
Hypersensitivity and anaphylactic/anaphylactoid reactions are known risks of immune globulin therapy, but FDA states that the increased reporting from this specific lot represents a heightened safety concern.
India caveat
This is a U.S. FDA safety alert. Indian healthcare facilities should also check CDSCO communications, local product availability and manufacturer/distributor instructions before taking regulatory action. The lot number should be matched exactly.
Official Source
U.S. FDA — IGIV lot with increased hypersensitivity reports, 6 October 2026
MedBodh note: This safety summary is for healthcare professionals and does not replace the current regulator or manufacturer instructions.
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