FDA WARNING_LETTER - Get.Fit.Medical, LLC dba Get.Fit.Medical - August 01, 2025

The FDA issued a Warning Letter to Get.Fit.Medical, LLC (dba Get.Fit.Medical) on September 9, 2025, following a review of the company’s website conducted in August 2025. The investigation found that the firm is marketing compounded versions of several drugs—including sildenafil, tadalafil, semaglutide, and tirzepatide—using false and misleading claims. Specifically, the company promoted these compounded products as "generic" versions of FDA-approved medications like Viagra, Cialis, Ozempic, Wegovy, and Mounjaro. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), compounded drugs are not FDA-approved and do not undergo the same safety and effectiveness reviews as approved brand-name or generic drugs. Therefore, labeling them as "generics" is a violation of sections 502(a) and 502(bb) regarding misbranding. The FDA considers the distribution of these misbranded products into interstate commerce a prohibited act. To resolve these issues, Get.Fit.Medical must take immediate action to correct the violations, such as removing the misleading language from its advertising. The company is required to provide a written response to the FDA within 15 working days detailing the specific corrective measures taken and the steps implemented to prevent recurrence. Failure to comply may lead to further legal actions, including product seizures or injunctions.