FDA WARNING_LETTER - Kare Solutions, LLC dba Zappy - December 31, 2025

The Food and Drug Administration (FDA) issued a Warning Letter to Kare Solutions, LLC, operating as Zappy, on February 20, 2026. This action followed a December 2025 review of the company's website, zappyhealth.com, which offers compounded drug products such as semaglutide, tirzepatide, and liraglutide. The primary issues identified involve false and misleading claims, rendering the products misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, Zappy's website falsely represents itself as the compounder of these drugs. Furthermore, the company makes claims, including associating its products with active ingredients in FDA-approved medications like Wegovy® and using phrases like "proven medication," which misleadingly suggest their compounded products are FDA-approved or evaluated for safety and effectiveness. Compounded drugs are not FDA-approved. These practices violate FDCA provisions, including sections 502(a) and 502(bb) related to false or misleading labeling and advertising, and 301(a) prohibiting the introduction of misbranded drugs into interstate commerce. Zappy is required to provide a written response within 15 working days, outlining concrete steps to address these issues and prevent recurrence. This includes identifying the actual entities compounding the products, providing representative product labeling, and modifying or removing all misleading website claims to ensure full compliance with federal law.