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The U.S. Food and Drug Administration has issued 18 warning letters to website operators illegally marketing unapproved and misbranded botulinum toxin products, often sold as Botox. The agency reports that some consumers have already experienced adverse events resembling botulism after using these unsafe products.

Botulinum toxin injections—commonly used for wrinkle reduction, migraines, and muscle disorders—are tightly regulated and available only by prescription. Approved products carry the FDA’s boxed warning due to the risk of severe side effects, including muscle weakness, difficulty breathing, and potentially death.

The FDA warns that products purchased from unauthorized online sources may be counterfeit, contaminated, mishandled, or ineffective, posing significant health risks. Consumers should only receive injections from licensed, trained medical professionals using products sourced directly from authorized distributors.

The agency named 18 websites in violation, including acecosm.com, aesthetic-essentials.com, dermaxshop.com, koreafillerexperts.com, and others. Anyone experiencing botulism-like symptoms after an injection—such as trouble swallowing or breathing—should seek immediate medical attention.

Health professionals and consumers are encouraged to report adverse events through the FDA’s MedWatch program