Walmart, Inc. – FDA Warning Letter, Jul 31, 2026

On October 1, 2026, the FDA issued a warning letter to Walmart, Inc. following a review of products purchased from its website in July 2026. The agency identified three products—"HClear for him," "Herstat GST," and "Terragen HG Formula"—as unapproved new drugs being sold directly to consumers via Walmart Fulfillment Services. These products are marketed for the treatment of sexually transmitted infections (STIs) and related symptoms, such as genital herpes and sores. Under the Federal Food, Drug, and Cosmetic Act, the FDA has not approved any over-the-counter drug for the treatment or prevention of STIs, as these conditions require professional medical diagnosis and supervision. The agency expressed significant concern that these products pose a public health risk, as consumers may forgo necessary medical care, leading to severe complications like infertility or sepsis, and an increased risk of disease transmission. The FDA further clarified that labeling products as homeopathic does not exempt them from federal safety and approval requirements. Walmart is required to investigate the root cause of these violations and submit a written response within 15 business days detailing the corrective and preventive measures taken to ensure future compliance.