FDA Issued Warning Letters Over Contaminated Vet Product
Regulators targeted two manufacturers after a wound solution caused severe infections in nearly 100 horses.
Updated on Sept. 29, 2026 in Pet Health
The FDA issued warning letters to Neogen Corp. and Sciarra Aeromed Inc. following a series of horse infections linked to their contaminated topical wound care product. At least 20 horses were euthanized after developing serious infections from the product.
Why it matters
The investigation highlights critical safety failures in veterinary product manufacturing, where improper sterility led to significant animal harm. The FDA intervention follows reports from veterinarians who observed adverse events after using the product.
The FDA identified contamination with various fungi, including Purpureocillium lilacinum and Isaria takamizusanensis, within the HYCOAT product. Neogen Corp. marketed the solution as a sterile device but failed to proactively report adverse events.
The players
FDA
The Food and Drug Administration is the federal agency responsible for protecting public and animal health by regulating veterinary devices and drugs.
Neogen Corp.
Neogen Corp. is an international manufacturer and supplier of animal safety products and diagnostics.
Sciarra Aeromed Inc.
Sciarra Aeromed Inc. is a company identified by the FDA for its role in the manufacturing process of the contaminated wound care solution.
The details
Although labeled as a topical wound management solution, the product was frequently used as an injection by veterinarians, contributing to the severity of the infections. Inspections of the manufacturing facility revealed insanitary conditions, prompting the FDA to take formal enforcement action.
Timeline
Late 2025: The FDA began receiving reports from veterinarians regarding adverse events.
Late January 2026: Neogen initiated a voluntary recall of the product HYCOAT.
September 2026: The FDA issued official warning letters to both manufacturers.
Roadmap
This enforcement action underscores the FDA's increasing scrutiny of companies marketing animal devices that bypass rigorous safety protocols. It signals a broader push to standardize sterility requirements for veterinary products to prevent similar outbreaks.
Horse owners should contact their veterinarian to confirm that any HYCOAT products previously used or currently in stock have been discarded as part of the recall. Veterinarians are advised to ensure all wound care supplies currently in use meet updated regulatory sterility standards.
The takeaway
Pet owners should prioritize asking veterinarians about the source and sterility of medical products used for their animals. Verifying that a device or solution is FDA-approved can prevent exposure to hazardous manufacturing defects.
Further reading
For more on maintaining animal health safety, visit Pet Health.
