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DirectMeds was cited for unlawfully selling unapproved and misbranded compounded drugs, specifically semaglutide and tirzepatide, over the internet to U.S. consumers. The company made false or misleading claims on its website asserting that its compounded products contained "the same active ingredients" and were equivalent to FDA-approved brand-name versions (Ozempic/Mounjaro), violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. The FDA's August 2025 website review found that DirectMeds' marketing implied its unapproved compounded formulations were therapeutically equivalent to approved drugs, which is unlawful since compounded drug products are not FDA-approved.