- The FDA issued warning letters to Neogen Corporation and Sciarra Aeromed following its investigation of Neogen Vet HYCOAT.
- FDA testing identified multiple fungi in the product, which was labeled as a sterile topical wound management solution.
- Nearly 100 horses reportedly developed serious joint infections after the product was administered, and at least 20 were humanely euthanized following unsuccessful treatment.
- Veterinarians had reported using HYCOAT as an injection, although the product was marketed as a veterinary device for topical wound management.
- Neogen voluntarily recalled HYCOAT nationwide in late January 2026.
- An FDA inspection of the manufacturing facility identified serious violations, including the manufacture of products labeled as sterile under insanitary conditions.
The U.S. Food and Drug Administration has issued warning letters to Neogen Corporation and Sciarra Aeromed following an investigation that linked fungal contamination of Neogen Vet HYCOAT to serious infections and deaths in horses.
HYCOAT, or hyaluronate sodium sterile solution, is marketed by Neogen as a veterinary device and labeled as a sterile topical wound management solution for surgical wounds, burns and similar conditions.
According to the FDA, nearly 100 horses developed serious joint infections following administration of the product, and at least 20 horses were humanely euthanized after treatment of the infections was unsuccessful.
The agency said the incident represents the largest number of horse deaths associated with a quality defect in an FDA-regulated veterinary medical product and the most deaths involving any animal species linked to microbiological contamination of an FDA-regulated product labeled as sterile.
The FDA noted that the reported fatalities represent only deaths reported to the agency. The total number of affected horses similarly includes only reports with enough information to confirm each as a unique case, and the agency has not received final outcomes for many of the injured horses.
FDA testing identifies multiple fungi
HYCOAT is packaged in a glass vial with a septum top, a packaging style commonly used for sterile injectable drugs. Beginning in late 2025, the FDA received reports from veterinarians who had used the product as an injection, although its labeling describes it as a topical wound management solution.
FDA testing found the product contaminated with multiple fungi, including Purpureocillium lilacinum, Paraisaria heteropoda, Gongronella lacrispora, Purpureocillium sodanum and Isaria takamizusanensis.
The agency said injecting a fungus-contaminated solution can lead to joint infection, tissue destruction and systemic illness.
The FDA specifically noted that P. lilacinum is particularly resistant to antifungal drugs, making infections involving the organism especially difficult to treat.
The agency also warned that contamination poses risks when the product is used topically as labeled. Microorganisms entering an open wound can potentially lead to infection, cellulitis, tissue necrosis and life-threatening sepsis.
Manufacturing inspection identifies violations
As part of its investigation, the FDA reviewed epidemiological and clinical evidence, collected and tested product samples, and inspected the manufacturing facility.
According to the agency, the inspection identified serious violations, including the manufacture of products labeled as sterile in a facility with insanitary conditions.
Neogen initiated a voluntary nationwide recall of HYCOAT in late January 2026.
Veterinarian reports prompted FDA investigation
The FDA said reports submitted directly by veterinarians played an important role in identifying the problem.
According to the agency, Neogen marketed HYCOAT as an animal device and did not proactively report adverse events to the FDA. The agency said it became aware of the emerging issue after veterinarians contacted it directly, triggering the investigation.
The FDA is encouraging veterinary companies, veterinarians and animal owners to report adverse events and product quality concerns involving veterinary products, regardless of whether a product is FDA-approved or used according to its labeling.
Information sourced from the U.S. Food and Drug Administration.
