FDA WARNING_LETTER - Viv Health, Inc. dba VIV RX - December 31, 2025

On February 20, 2026, the FDA issued a Warning Letter to Viv Health, Inc. dba VIV RX, following a December 2025 review of its website, vivrx.com. The primary violation identified was the misbranding of compounded semaglutide and tirzepatide drug products. The FDA found that VIV RX"s website displayed these compounded drugs with "VIV RX" on the labels, falsely suggesting the company was the compounder. This misrepresentation means the products are misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), which prohibits false or misleading drug labeling and advertising for compounded drugs. Introducing these misbranded products into interstate commerce also constitutes a prohibited act under FDCA section 301(a). The FDA mandates immediate action from VIV RX. The company must provide a written response within fifteen working days, detailing specific steps taken to correct the violations and prevent their recurrence. This response should include identifying the actual producers of the compounded products, providing representative sample labeling, and addressing or removing other false or misleading claims on its website. Failure to adequately address these concerns could lead to further legal actions, including seizure and injunction. This warning emphasizes the company"s responsibility to ensure full compliance with federal law and FDA regulations.