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FDA Issues Warning Letters to 18 Websites Selling Unapproved Botox-Like Injectables

The action follows reports of botulism-like injuries tied to counterfeit injections sold online.

ARLINGTON, VA - JUNE 05: Recently laid off worker Lyn Talent receives a free Botox injection during an event called the "The Botox Bailout" where the first 50 recently laid-off workers could exchange their resumes for free Botox injections June 5, 2009 in Arlington, Virginia. The event, which took place in a Reveal store, also featured recruiters to help job seekers network, collect resumes and offer on-site interviews. (Photo by Win McNamee/Getty Images)
FILE - A patient receives a Botox injection at a clinic in Arlington, Va., on June 5, 2009. (AP Photo/Jacquelyn Martin, File)
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Overview

  • The FDA said the targeted retailers illegally marketed unapproved or misbranded botulinum toxin products often advertised as Botox.
  • The agency publicly named 18 websites, including acecosm.com, maypharm.net, glamderma.com, koreanfillers.com and filleroutlet.com.
  • Officials cited adverse events, with the CDC documenting at least 22 cases across 11 states from November 2023 to March 2024, including 11 hospitalizations.
  • FDA-approved botulinum toxin products carry a boxed warning because the toxin can spread beyond the injection site and cause life‑threatening effects.
  • Health authorities advise receiving injections only from licensed, trained professionals and seeking immediate care for symptoms such as trouble breathing, swallowing difficulties, slurred speech or muscle weakness, with ongoing scrutiny of foreign products like Innotox and self-injection trends.