FDA Recall: Neogen Vet HYCOAT Hyaluronate Sodium Sterile Solution Contaminated With Microbes
Immediate Action Required: Neogen Corporation has issued a nationwide, voluntary recall of all in-date lots of Neogen Vet HYCOAT® Hyaluronate Sodium Sterile Solution. Quality testing confirmed microbial contamination, meaning the product is no longer sterile and could cause serious infections in dogs, cats, and horses. Discontinue use, quarantine remaining vials, and follow the return instructions below.
Why Was Neogen Vet HYCOAT Sterile Solution Recalled?
During routine testing, Neogen detected microbial contamination in certain 10 mL / 50 mg vials. To protect animal health, the firm expanded the recall to every lot of both package sizes currently within expiry:
- 10 mL / 50 mg vials – UPC 726087089393
- 2 mL / 20 mg vials – UPC 726087089386
Although HYCOAT is labeled for topical wound management, multiple adverse events occurred in horses when it was improperly administered intra-articularly. Injecting a contaminated solution into joints, surgical sites, or burns dramatically increases the risk of infection.
Complete List of Neogen Vet HYCOAT Lot Numbers
2 mL / 20 mg vials
0236735, 0236736, 0336746, 0336747, 0536760, 0536761, 0636768, 0636769, 0836792, 0836785, 0836788, 0836789, 0936794, 0936795, 1036801, 1036802, 1036803, 1036804, 1136807, 1136808, 0246837, 0246838, 4L001B, 4L002
10 mL / 50 mg vials
0136731, 0736777, 0346843, 5A001
Required Actions for Veterinarians and Distributors
- Cease administering or dispensing Neogen Vet HYCOAT immediately.
- Isolate all inventory to prevent accidental use.
- Email AnimalHealth@neogen.com or call 859-254-1221 (Mon–Fri, 8 AM – 5 PM ET) for prepaid return labels.
- Report suspected adverse events to FDA CVM via Form FDA 1932a or 1-888-FDA-VETS.
Health Risks Posed by Contaminated Neogen Vet HYCOAT
Loss of sterility can lead to:
- Joint, wound, or burn infections
- Delayed tissue healing
- Systemic illness or sepsis in severe cases
No complications have been reported when HYCOAT was used solely as a topical dressing. Nevertheless, practitioners should monitor treated animals for any signs of infection.
Source
Frequently Asked Questions
Is every Neogen Vet HYCOAT lot included in the recall?
Yes. Neogen voluntarily recalled all lots within expiry of both 2 mL and 10 mL presentations.
Can I keep using Neogen Vet HYCOAT topically if the vial looks fine?
No. Visual inspection cannot verify sterility. Dispose of or return the product even if there is no visible contamination.
How do I obtain a refund or replacement for Neogen Vet HYCOAT?
Contact Neogen Animal Safety Customer Support at 859-254-1221 or AnimalHealth@neogen.com. A prepaid shipping label will be provided, and credit will be issued upon receipt.
What symptoms indicate a possible Neogen Vet HYCOAT–related infection?
Watch for swelling, heat, pain, discharge, delayed healing, fever, or lethargy. Seek veterinary care immediately if any of these signs develop.
Are any other Neogen veterinary products affected by this recall?
No. Neogen confirmed that only Neogen Vet HYCOAT is subject to the current recall.
Where was Neogen Vet HYCOAT manufactured?
The product was manufactured in Lexington, Kentucky, under Neogen Corporation’s animal safety division.
Has the FDA classified the Neogen Vet HYCOAT recall severity?
As of this writing, the FDA has not yet assigned a recall classification (Class I, II, or III). The agency is reviewing the firm’s submitted information.