FDA WARNING_LETTER - Reset IV, LLC dba Reset IV - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to Reset IV, LLC (doing business as Reset IV) following a review of the company"s website conducted in August 2025. The investigation focused on the marketing of compounded drug products, specifically semaglutide and tirzepatide. The FDA found that Reset IV engaged in false or misleading advertising by claiming their compounded products were the same as FDA-approved medications such as Wegovy, Ozempic, Zepbound, and Mounjaro. Because compounded drugs are not FDA-approved, the agency determined that these claims are deceptive and misbrand the products under the Federal Food, Drug, and Cosmetic Act. The introduction of these misbranded drugs into interstate commerce is a violation of federal law. The FDA has directed Reset IV to take immediate action to correct these violations, which includes ceasing the use of misleading promotional language. The company is required to submit a written response within 15 working days detailing the specific steps taken to address the issues and prevent their recurrence. Failure to comply with these requirements may lead to further legal action, such as product seizures or court-ordered injunctions.