FDA Warning Letter to AM RX Over Compounded Semaglutide Marketing and Ozempic Active-Ingredient Claims
On June 8, 2026, FDA issued a warning letter to FitRX, LLC dba AM RX after a March 2026 review of getamrx.com, which offers compounded semaglutide and tirzepatide products. FDA says pictured labels identify "AM Rx" as if it were the compounder "when in fact it is not," and cites website claims including "Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price," which FDA says represent unapproved compounded products as FDA-approved. FDA requested a written response within 15 business days.
What this means"Same active ingredient" marketing can blur the line between an FDA-approved drug and a compounded copy that has never been through FDA review — a distinction worth understanding before ordering through any telehealth platform.
Source: FDA original ↗