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Mexicanrxpharm.com was cited for introducing unapproved and misbranded opioid drugs into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (sections 301(a), 301(d), 503(b), and 505(a)). The company sold these drugs directly to U.S. consumers over the Internet without FDA approval, creating significant public health risks given the ongoing opioid epidemic. Unapproved drugs sold through this channel posed dangers including potential contamination, counterfeit products, inconsistent active ingredient amounts, and unknown ingredient substitutions that circumvented FDA safety and efficacy oversight. The FDA requested that the company cease all sales of unapproved and misbranded drugs to U.S. consumers.