FDA recalls Neogen Vet HYCOAT after severe contamination scandal impacts over 95 horses

London: The FDA has recalled Neogen Vet HYCOAT following fungal contamination linked to the death of at least 20 horses, highlighting oversights in manufacturing, packaging issues, and the importance of swift regulatory action in safeguarding animal health.

Neogen Vet HYCOAT, sold as a sterile hyaluronate sodium solution, has been tied by the FDA to one of the most severe veterinary contamination scandals in recent years, with more than 95 affected horses and at least 20 deaths. The episode has sharpened scrutiny of contract manufacturing oversight, product classification and how quickly regulators and companies warn the market when animal safety is at risk. For veterinarians and animal health suppliers, the case underscores how a quality failure can become a sector-wide trust problem.

According to the FDA, Neogen’s voluntary recall began in late January 2026 after adverse event reports from horses treated with the product. The agency later found multiple fungal species in vials, including Purpureocillium lilacinum, and said the contamination caused infection, tissue destruction and systemic illness.

The FDA’s warning letter to Neogen, issued on 23 September 2026, said the company failed to exercise adequate oversight of its contract manufacturer, Sciarra Aeromed. Inspectors found insanitary conditions at the plant and concluded that the product was adulterated under the Federal Food, Drug, and Cosmetic Act.

The contamination appears to have been amplified by a dangerous mismatch between presentation and use: the product was being injected into joints despite being marketed in packaging that veterinarians did not treat as a topical-only device. The recall therefore became not just a quality-control failure, but a warning about labelling, channel management and the limits of private disclosure when animal health is on the line.

Source: Noah Wire Services