RoenRx — FDA Warning Letter (June 8, 2026)

Violations were identified and documented during a review of RoenRx’s website, https://roenrx.com, FDA Establishment Identifier (FEI) 3044022969, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide products. As described below, your website’s false or misleading claims concerning compounded semaglutide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.

Your representations regarding compounded semaglutide products are false or misleading. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FD&C Act [21 U.S.C. § 352(bb)], a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular.

1. The compounded semaglutide products displayed on your website identify “RoenRx” on the pictured label, suggesting RoenRx is the compounder of those drugs when in fact it is not.

2. The following claims concerning compounded semaglutide products appear on your website: “Semaglutide is the active ingredient in FDA-approved medications like Wegovy and Ozempic….” “RoenRx also offers semaglutide, the active ingredient in Wegovy® and Ozempic®….” “Get affordable semaglutide (main ingredient in Ozempic® & Wegovy®) at an affordable price.”

Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.