FDA WARNING_LETTER - Maypharm - November 01, 2025

On November 3, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Maypharm, a company based in South Korea, following a review of its website, www.maypharm.net. The FDA"s Center for Drug Evaluation and Research (CDER) identified significant violations, primarily the introduction of unapproved new drugs and misbranded drugs into interstate commerce. Specifically, Maypharm was found to be selling injectable botulinum toxin drug products, such as "BOTULAX 200 units" and "Botulax 200ui," which are not approved by the FDA for sale in the United States. These products are classified as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they lack FDA approval for safety and effectiveness. Furthermore, they are misbranded as they are prescription-only drugs marketed without adequate directions for use by a layperson, failing to meet labeling requirements. The FDA emphasized the serious health risks associated with unapproved injectable drugs, which can include contamination, inconsistent active ingredients, and life-threatening conditions. Maypharm is mandated to immediately cease offering these unapproved and misbranded drugs to U.S. consumers. The company must provide a written response within 15 working days, outlining concrete steps taken to address the violations, prevent their recurrence, and ensure overall compliance with the FD&C Act, including a thorough review of all product labeling and promotional materials.