Neogen Corporation – FDA Warning Letter, Sep 1, 2026

Neogen Corporation received a Warning Letter from the FDA on September 23, 2026, following a multi-state investigation into serious adverse events and horse fatalities linked to its product, HYCOAT® (Hyaluronate Sodium Sterile Solution). The FDA’s investigation, which included inspections of the contract manufacturing facility, revealed that the purportedly sterile product was contaminated with multiple fungal species. This contamination was associated with the highest number of equine deaths ever recorded for a quality defect in a veterinary medical product. The main violations include manufacturing the drug under insanitary conditions—such as inadequate cleaning, poor air quality monitoring, and a facility in disrepair—and misbranding the product. The FDA found that the labeling lacked adequate directions for use and failed to include necessary warnings for common off-label uses. These issues constitute violations of the Federal Food, Drug, and Cosmetic Act. As the distributor, Neogen is held responsible for ensuring its products meet safety and quality standards. The FDA requires the company to submit a written response within 15 working days detailing the corrective actions taken to address these violations and prevent their recurrence. Failure to provide a sufficient response may result in further regulatory or legal action.