FDA WARNING_LETTER - Remedy Meds - August 01, 2025

On September 9, 2025, the FDA issued a Warning Letter to Remedy Meds following a review of the company’s website in August 2025. The agency found that the company was marketing compounded semaglutide and tirzepatide products using false and misleading claims. Specifically, the website suggested these compounded products were identical to FDA-approved drugs like Ozempic, Wegovy, Mounjaro, and Zepbound by claiming they shared the "same active ingredient." The FDA determined that these claims are deceptive because compounded drugs are not FDA-approved and cannot be marketed as being the same as approved medications. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, these products are considered misbranded, and their distribution across state lines is prohibited. To address these violations, Remedy Meds must immediately remove the misleading marketing language and investigate the root causes of the non-compliance. The company is required to provide a written response to the FDA within 15 working days, outlining the specific corrective actions taken and the measures implemented to prevent recurrence. Failure to resolve these issues may lead to legal action, including product seizures or court-ordered injunctions.