FDA WARNING_LETTER - Weightless Medical LLC dba WeightCare - December 31, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Weightless Medical LLC, operating as WeightCare, on February 20, 2026. The agency's review of the company's website, joinweightcare.com, in December 2025, revealed that WeightCare offers compounded drug products, specifically semaglutide and tirzepatide. The primary violation identified was that the company's website displays labels for these compounded products suggesting "WeightCare" is the compounder, which is false and misleading. This misrepresentation causes the products to be "misbranded" under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), which address false or misleading labeling and advertising of compounded drugs. Introducing these misbranded products into interstate commerce is a prohibited act under section 301(a) of the FDCA. WeightCare is required to take immediate corrective action. The FDA demands a written response within 15 working days detailing specific steps taken to resolve the violations and prevent their recurrence. This must include identifying the actual manufacturers of the compounded products, providing representative sample labeling, and addressing or removing other potentially misleading website claims. Failure to comply could lead to legal action, including product seizure or injunction.