Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration (FDA) issued a safety alert in October 2025 concerning several lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) products. The FDA Adverse Event Reporting System (FAERS) has observed an increased number of allergic and hypersensitivity reactions linked to specific product lots. These adverse events included serious hypersensitivity reactions, some requiring emergency medical interventions such as epinephrine administration, corticosteroids, and hospital admissions. Although hypersensitivity reactions are a known risk of immune globulin therapy, the increased frequency identified in these lots signals heightened safety concerns for patients receiving these infusions.
Affected Products and Lots
The FDA has identified specific lots from manufacturers ADMA Biologics and Grifols as having increased reports of allergic/hypersensitivity reactions. Healthcare providers and patients are advised to immediately check inventories and discontinue use of the following lots:
Product | Lot Number | Expiration Date | Manufacturer |
Asceniv | 239825 | 31-Aug-2027 | ADMA Biologics |
Bivigam | 237452 | 31-Oct-2027 | ADMA Biologics |
Gammaked | B03J086043 | 31-Aug-2027 | Grifols for Kedrion |
Gamunex-C | B01J100623, | 03-Oct-2027 | Grifols |
Gamunex-C | B03J077152 | 10-Oct-2027 | Grifols |
Gamunex-C | B03J079503 | 16-Aug-2027 | Grifols |
Other affected lots had been voluntarily withdrawn earlier in 2025 due to similar hypersensitivity concerns, including Xembify, Panzyga, and additional lots of Bivigam and Gamunex-C
Nature of Adverse Reactions
Reported reactions ranged from mild allergic symptoms such as urticaria and itching to severe anaphylactic or anaphylactoid responses that required immediate treatment with epinephrine and corticosteroids. Several events led to emergency room visits or hospitalizations. These allergic reactions mirror known immune globulin risks but at a higher-than-expected frequency for these particular lots, urging caution among clinicians and patients.
FDA Recommendations
Immediate Inventory Check: Healthcare facilities and providers should immediately identify if they possess any vials from the affected lots.
Cease Use: All use of these identified lots should stop immediately to prevent further adverse events.
Contact Manufacturer: For any questions regarding the affected lots, manufacturers should be contacted directly.
Adverse Event Reporting: Physicians and patients are encouraged to report any suspected adverse events related to immune globulin products to the FDA MedWatch program at 1-800-FDA-1088 or via the FDA website.
Background on IGIV and IGSC Hypersensitivity
Hypersensitivity and anaphylaxis are documented risks in the use of immune globulin therapies due to immune reactions to the infused proteins. These reactions can be immediate or delayed and may include symptoms such as rash, wheezing, hypotension, and severe anaphylaxis. Previous voluntary lot withdrawals since early 2025 have already highlighted ongoing vigilance on this safety aspect by regulatory authorities and manufacturers.
References
Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions, 28 October 2025, https://www.fda.gov/vaccines-blood-biologics/immune-globulin-intravenous-igiv-andor-immune-globulin-subcutaneous-igsc-lots-increased-reports
The United States: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions, Drug Office, Department of Health, The Government of Hong Kong Special Administrative Region, 25 Oct 2025, https://www.drugoffice.gov.hk/eps/news/showNews/IGIV/pharmaceutical_trade/2025-10-25/en/56280.html
FDA MedWatch – Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC), TOPIC: Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals – Due to Increased Reports of Allergic/Hypersensitivity Reactions, 11 March 2025, https://content.govdelivery.com/accounts/USFDA/bulletins/3d5e01b
Guo Y, Tian X, Wang X, Xiao Z. Adverse Effects of Immunoglobulin Therapy. Front Immunol. 2018 Jun 8;9:1299. Doi: 10.3389/fimmu.2018.01299. PMID: 29951056; PMCID: PMC6008653.
Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals – Due to Increased Reports of Allergic/Hypersensitivity Reactions, 11 March 2025, US FDA, https://www.fda.gov/safety/medical-product-safety-information/immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc-voluntary-lot-withdrawals-due
Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop, 02 Aug 2023, US FDA, https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/immune-globulin-hypersensitivity-reactions-root-causes-and-mitigation-public-workshop-03302023