FDA WARNING_LETTER - Ivim Services LLC dba Ivim - December 31, 2025

On February 20, 2026, the FDA issued a Warning Letter to Ivim Services LLC dba Ivim, following a December 2025 review of their website, ivimhealth.com. The primary violation identified was the misbranding of compounded semaglutide and tirzepatide drug products. The FDA found that Ivim"s website falsely implied the company was the compounder of these drugs, which is misleading to consumers. This misrepresentation constitutes false or misleading claims in labeling and advertising, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). Introducing these misbranded products into interstate commerce is also a prohibited act under FDCA section 301(a). Ivim is required to take immediate action. Within 15 working days, they must provide a written response to the FDA outlining specific steps taken to address these violations and prevent recurrence. This includes identifying the entities that produce the compounded products offered, providing representative sample labeling, and modifying or removing any other false or misleading claims on their website. Failure to adequately address these violations may result in further legal action.