10/31/2026
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WhoaZone Equine | Equine Health & Industry News | www.WzEquine.com
October 29, 2026
A product used in equine veterinary medicine has become the center of a devastating contamination incident involving an FDA-regulated veterinary medical product.
On September 29, 2026, the U.S. Food and Drug Administration announced that its investigation had linked fungal contamination in Neogen Vet HYCOAT, a hyaluronate sodium sterile solution, to serious joint infections in nearly 100 horses. At least 20 horses were humanely euthanized after treatment attempts were unsuccessful.
According to the FDA, the incident represents the largest number of reported horse deaths associated with a quality defect in an FDA-regulated veterinary medical product.
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HYCOAT is a hyaluronate sodium solution distributed by Neogen Corporation and manufactured by a third-party supplier.
Hyaluronic acid is a naturally occurring component of joint fluid and cartilage. Injectable hyaluronic acid products are commonly used in equine veterinary medicine to support joint function and manage certain inflammatory joint conditions, particularly in performance horses.
However, there is an important face to note in this case.
Neogen Vet HYCOAT was labeled as a sterile topical wound management product, not as an injectable joint medication. Despite that labeling, veterinarians had been administering the product through intra-articular injections, meaning directly into the joint space. This was an off-label application.
The product's glass vial packaging, which included a septum similar to those used for injectable medications, may also have contributed to confusion about its intended administration. The FDA identified concerns about the product's labeling and the absence of adequate warnings regarding this known off-label use.
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During its investigation, the FDA collected and analyzed samples of HYCOAT. Laboratory testing confirmed microbiological contamination in lot 5A001.
Five fungal species were identified:
1. Purpureocillium lilacinum
2. Paraisaria heteropoda
3. Gongronella lacrispora
4. Purpureocillium sodanum
5. Isaria takamizusanensis
Of particular concern was Purpureocillium lilacinum, an organism known for resistance to multiple antifungal medications. Unlike many bacterial joint infections, fungal infections can be particularly challenging to diagnose and treat. Organisms introduced into a joint may establish infections that are difficult to eliminate, even with aggressive veterinary intervention.
Once inside the joint, fungal contamination can trigger severe inflammation, damage synovial tissues, compromise cartilage and potentially result in permanent lameness. In advanced cases, the infection may become unresponsive to treatment, leaving euthanasia as the most humane option.
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Septic arthritis is among the most serious complications associated with joint injections in horses.
A healthy joint is a tightly regulated environment. Introducing infectious organisms directly into the joint capsule bypasses many of the body's natural protective barriers.
Fungal septic arthritis can be particularly destructive because of the organisms' ability to persist in tissue and their sometimes limited susceptibility to available antifungal medications.
Clinical signs may include pronounced lameness, joint swelling, heat, pain, reduced range of motion and changes in synovial fluid.
Treatment may require repeated joint lavage, arthroscopic intervention, antifungal medications and extended hospitalization. Even with treatment, the prognosis can be guarded, particularly when diagnosis is delayed or substantial cartilage damage has occurred.
For horses competing in reining, cutting, barrel racing, jumping and other athletic disciplines, the consequences can extend far beyond time away from competition. Severe joint damage can permanently end a performance career.
Any horse developing significant lameness or joint swelling following an injection should receive prompt veterinary evaluation.
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The investigation extended beyond the infected horses and contaminated product samples. FDA inspectors evaluated the facility responsible for manufacturing HYCOAT and identified significant deficiencies in the conditions under which the product was produced.
The agency documented concerns involving environmental monitoring, cleaning and disinfection procedures, personnel practices and other controls necessary for sterile manufacturing. The FDA determined that HYCOAT had been manufactured under insanitary conditions and issued warning letters to both Neogen Corporation and Sciarra Aeromed, Inc.
The findings raise questions about manufacturing oversight, quality assurance and the safeguards necessary to protect animals receiving veterinary medical products. While Neogen contracted with another company to manufacture HYCOAT, the FDA emphasized the distributor's responsibility for products marketed under its label.
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On January 28, 2026, Neogen announced a voluntary nationwide recall of all unexpired lots of Neogen Vet HYCOAT Hyaluronate Sodium Sterile Solution.
The recall included both the 2 mL and 10 mL presentations.
Neogen stated that the recall followed reports of adverse events in horses receiving intra-articular injections, which were inconsistent with the product's labeled intended use.
The company also reported that it had not received adverse event reports associated with use according to the product's topical wound management labeling at the time of its recall announcement.
However, the FDA emphasized that microbial contamination also presents risks when a product is applied to open wounds, including potentially serious infections and systemic complications.
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The FDA's findings highlight the importance of communication between horse owners and their veterinarians, particularly when injectable medications or joint therapies are being administered.
Owners should understand what products are being used, whether those products are labeled for the intended route of administration, and what risks are associated with treatment.
Veterinary practices should review their inventories for recalled HYCOAT products and ensure affected vials are removed from use and quarantined.
For horses previously treated with HYCOAT, especially those that experienced unexplained lameness, joint swelling or persistent inflammation following treatment, owners should discuss their horse's medical history with their veterinarian.
Treatment records, product names, lot numbers and administration dates may be valuable when evaluating a suspected adverse event.
This recall concerns a specific product, not all hyaluronic acid products or all equine joint injections.
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One of the most concerning findings from the FDA's announcement was how the problem came to the agency's attention. According to the FDA, Neogen did not proactively report the adverse events to the agency. Instead, veterinarians independently contacted federal regulators about the infections they were encountering.
Those reports helped initiate the investigation that ultimately identified the contamination. The FDA has acknowledged that the true scope of the incident remains uncertain. The reported fatalities represent only those known to the agency, and final outcomes have not been established for many affected horses.
This reinforces the importance of documenting and reporting suspected veterinary product complications, particularly when similar clinical presentations begin appearing across unrelated veterinary practices.
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Behind these findings are horses, owners, trainers and veterinary teams who faced devastating outcomes from what may have begun as routine veterinary care.
For the performance horse industry, where joint health and soundness are essential to both animal welfare and athletic longevity, the implications are significant.
Veterinary medicine depends on confidence in product quality, sterile manufacturing and responsible clinical decision-making. Confidence requires accountability throughout the process, from the manufacturer and distributor to the veterinary professional administering treatment.
The HYCOAT investigation demonstrates how failures in sterile product manufacturing can have catastrophic consequences. It also demonstrates the importance of veterinarians speaking up when they recognize unusual patterns of complications.
For the horses that lost their lives, the consequences cannot be reversed. But greater awareness, stronger quality controls and timely reporting may help prevent similar tragedies in the future. For horse owners, the message is clear: Know what is being administered to your horse, maintain accurate veterinary records and never dismiss unexplained complications following a joint injection.
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1. U.S. Food and Drug Administration. FDA Issues Warning Letters Following Fungal Contamination of Veterinary Product Linked to Serious Infections in Horses. September 29, 2026.
https://www.fda.gov/animal-veterinary/cvm-updates/fda-issues-warning-letters-following-fungal-contamination-veterinary-product-linked-serious
2. U.S. Food and Drug Administration. Warning Letter to Neogen Corporation. September 23, 2026.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neogen-corporation-731018-09232026
3. U.S. Food and Drug Administration. Neogen Issues Voluntary Nationwide Recall of Neogen Vet HYCOAT Hyaluronate Sodium Sterile Solution. January 28, 2026.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/neogen-issues-voluntary-nationwide-recall-neogenrvet-hycoatr-hyaluronate-sodium-sterile-solution
4. U.S. Food and Drug Administration. Reporting Adverse Events and Product Problems in Animals.
https://www.fda.gov/reportanimalae
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This article is based on information reported by the U.S. Food and Drug Administration and other cited sources. WhoaZone Equine is sharing this information for educational purposes and to promote awareness within the equine community. This article is not intended to provide veterinary advice, diagnosis or treatment recommendations. Please consult with your licensed veterinarian regarding any questions or concerns about your horse's health, previous treatments or potential exposure to affected products.
