RegulatoryOfficial

FDA lists 2026 voluntary withdrawals of eight IGIV and IGSC lots over hypersensitivity reactions

🇺🇸 FDA CBER · Mon 26 Oct 2026

Manufacturers have pulled lots of Alyglo, Gammaked, Gamunex-C and Yimmugo after a higher rate of allergic reactions, some considered medically significant, FDA's biologics centre reports.

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has published a list of calendar year 2026 voluntary lot withdrawals of intravenous and subcutaneous immune globulin products. According to the notice, manufacturers withdrew the lots as a precaution because of a higher rate of allergic or hypersensitivity-type reactions, some of which were considered medically significant.

Eight lots are listed. Three are Alyglo lots from GC Biopharma Corp. (394C25018, 394C25019 and 394C25020), all withdrawn on 30 July 2026. Gammaked lot B13K127733, made by Grifols for Kedrion, and Gamunex-C lot B23L053203, made by Grifols, were both withdrawn on 11 August 2026. Biotest AG withdrew Yimmugo lots C795145 and C795165 on 13 August 2026, and a further Yimmugo lot, C795314, on 7 October 2026.

Expiry dates for the listed lots run from April 2027 to April 2029. The notice says hypersensitivity and anaphylactic or anaphylactoid reactions are a known risk with immune globulin products. It does not give case numbers or describe the reactions in more detail.

FDA asks users to check stock immediately for vials from the listed lots and to stop using any they find. Affected product should be returned to the point of purchase for replacement. The page was marked as current as of 7 October 2026.

What it means for your team

  • Check inventory, distribution records and customer shipments against the eight listed lot numbers, and quarantine any matches.
  • Pharmacovigilance teams should monitor hypersensitivity and anaphylactic case reports for Alyglo, Gammaked, Gamunex-C and Yimmugo, and check lot numbers in incoming reports.
  • Quality and supply teams should arrange returns and replacement through the point of purchase, as FDA directs, and keep records of the action taken.
  • The notice gives no figures on reaction rates or numbers of cases, so companies should look to manufacturers for further detail.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

More Regulatory All →