Tri-Star Equine Marketing LLC is recalling 1,958 units of Gastrotec, which contains the active ingredients Omeprazole (2.28 g) and Misoprostol (1.4 mg). This product is being recalled because it was marketed without an approved new animal drug application, meaning its safety and effectiveness have not been reviewed or verified by the FDA. The recall affects all lots and all expiration dates distributed across 18 states. Consumers who have purchased this product should stop using it for their animals immediately and contact their veterinarian.
Because Gastrotec is an unapproved drug, its manufacturing process, safety profile, and clinical effectiveness have not been evaluated, which may lead to ineffective treatment or harmful side effects in horses. No injuries have been reported to date, but the use of unverified medications poses a moderate risk to animal health.
Unapproved animal drug refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response