Botox should only be given by licensed medical professionals using FDA-approved products, the agency warned
THURSDAY, Nov. 6, 2025 (HealthDay News) — U.S. regulators have issued warnings to 18 websites that were selling fake or unapproved versions of Botox and similar wrinkle-relaxing injections.
The U.S. Food and Drug Administration (FDA) said it took immediate action after receiving reports of people getting injured by the products, including cases of botulism.
Botox is made from a purified form of botulinum toxin, one of the strongest toxins in the world.
When it”s used correctly, it blocks nerve signals and relaxes muscles, which can smooth wrinkles or help treat medical conditions such as migraines, eye disorders and muscle spasms.
The FDA also said the websites were advertising injectable products that looked like Botox but were not approved in the United States.
All FDA-approved Botox products come with the agency’s strongest safety alert — a so-called boxed warning — because the toxin can sometimes spread beyond the injection site and affect muscles needed for breathing or swallowing, The Associated Press reported.
That risk becomes even more dangerous when people receive products that aren’t inspected, tested or handled by licensed medical professionals.
Symptoms of botulism can include trouble breathing or swallowing, slurred speech, muscle weakness and drooping eyelids.
More information
The Cleveland Clinic has more on botulism.
SOURCE: The Associated Press, Nov. 5, 2025
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