FDA Issues Warning Letters Following Fungal Contamination in a Veterinary Product Linked to Serious Infections in Nearly 100 Horses

September 29, 2026

At least 20 of the horses had to be humanely euthanized

The U.S. Food and Drug Administration recently issued warning letters to Neogen Corporation and Sciarra Aeromed, Inc., following an investigation that linked a veterinary wound care product labeled as sterile, Neogen Vet HYCOAT (hyaluronate sodium sterile solution), to serious infections and deaths in horses. This incident involved at least 20 horse deaths, making it the largest number of horse deaths ever associated with a quality defect in an FDA-regulated veterinary medical product and the most deaths of any animal species linked to microbiological contamination of an FDA-regulated product labeled as sterile. Neogen initiated a voluntary recall of HYCOAT in late January 2026.

Total fatalities reflect only those deaths reported to the FDA. The total number of affected horses only includes cases reported to the FDA with sufficient identification to confirm each as a unique case. To date, the FDA has not been informed of the final case outcome for many of the injured horses.

Read more on the FDA website

Request a Consultation

★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.

R.G. Client

I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.

Mike H. Client

Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.

Dr. Sastry Client

I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.

Claire P. Client