FDA WARNING_LETTER - Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics - December 31, 2025

The FDA issued a Warning Letter to Deluxe IV Aesthetics PLLC, operating as Deluxe IV and Aesthetics, on February 20, 2026, following a website review conducted in December 2025. The letter identified significant violations concerning compounded semaglutide and tirzepatide drug products advertised on the company's website.

The main issues cited were misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the company"s website falsely suggested Deluxe IV and Aesthetics was the compounder of these drug products. Additionally, the website made misleading claims, such as "Same active pharmaceutical ingredient in Ozempic® and Mounjaro®," which could imply the compounded products were FDA-approved or evaluated for safety and effectiveness, despite compounded drugs lacking such approval. These actions represent the introduction of misbranded drugs into interstate commerce, a prohibited act under section 301(a) of the FDCA.

Deluxe IV and Aesthetics is required to provide a written response to the FDA within fifteen working days. This response must detail specific steps taken to address the violations and prevent their recurrence. Key actions include identifying the entities that produce the compounded products, providing representative labeling samples, and modifying or removing all false or misleading claims from their website. Failure to comply may result in further legal action, including seizure or injunction.