FDA WARNING_LETTER - Zeuss LLC dba Zeuss - December 31, 2025

The FDA issued a Warning Letter to Zeuss LLC dba Zeuss on February 20, 2026, following a December 2025 review of its website, getzeuss.com. The letter identifies significant violations related to the promotion and sale of compounded tirzepatide drug products. The primary issues identified were that Zeuss's website misrepresented the company as the compounder of these products and made unsubstantiated claims implying FDA approval or evaluation for safety and effectiveness. Such statements, like "FDA approved and clinically proven to work treatment for weight loss" and "each batch rigorously tested for efficacy and safety," are false for compounded drugs, which are not FDA-approved. These misrepresentations cause the products to violate federal drug labeling and advertising regulations, specifically sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), rendering them unlawful for interstate commerce under section 301(a). Zeuss is required to take immediate action. Within fifteen working days, the company must submit a written response detailing specific steps taken to correct the violations and prevent their recurrence. This includes identifying the actual producers of the compounded products, providing representative labeling samples, and modifying or removing false or misleading website claims. Failure to comply may lead to further legal action.