FDA WARNING_LETTER - Trinity HealthCare Supply, LLC dba altRx - May 01, 2026

In June 2026, the FDA issued a warning letter to Trinity HealthCare Supply, LLC, doing business as altRx, following an evaluation of the company’s website in May 2026. The review focused on the sale of compounded semaglutide and tirzepatide products used for weight loss. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act, primarily involving the misbranding of these medications. Specifically, altRx displayed labels suggesting it was the manufacturer when it was not, and made claims that the products were "clinically proven." These statements misleadingly imply the drugs have undergone rigorous FDA approval or safety evaluations, which compounded medications do not receive. Under the regulatory framework of the FD&C Act, advertising and labeling must be truthful and not misleading. To achieve compliance, altRx must submit a written response within 15 business days outlining its corrective actions. This includes identifying the actual manufacturers of the products, providing accurate labeling samples, and removing all false or misleading claims from its website. The FDA warns that failure to rectify these issues promptly could lead to legal consequences such as product seizures or injunctions.