FDA warns websites selling unapproved Botox for cosmetic purposes
[November 06, 2025]
By MATTHEW PERRONE
Associated Press (AP) — U.S. health regulators on Wednesday sent warning
letters to 18 websites selling counterfeit or unapproved versions of
Botox and similar injectable drugs commonly used to smooth wrinkles.
The Food and Drug Administration said it was taking action after
receiving reports of injuries in connection with the products, including
toxic side effects.
Botox is a diluted, purified form of botulinum, one of the most toxic
substances in the world. The ingredient works by temporarily blocking
nerve signals and causing muscles to relax. While most famously approved
for cosmetic use, Botox is also approved in the U.S. for a number of
medical conditions, including muscle spasms, eye disorders and
migraines.
The FDA warning letters mostly went to cosmetic websites. In each case,
the FDA said the companies were offering unofficial or mislabeled
versions of Botox-like drugs that haven't been approved by the agency.
In addition to the original drug, introduced by Allergan in 1989, the
FDA has approved several competing versions.
FDA-approved Botox drugs carry the agency's most serious warning, a
boxed label alerting doctors and patients that the medications can cause
serious or life-threatening side effects.
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A patient receives a Botox injection at a clinic in Arlington, Va.,
on June 5, 2009. (AP Photo/Jacquelyn Martin, File)
 In rare cases, the toxin can spread
beyond the injection site to other parts of the body, paralyzing or
weakening muscles needed for breathing and swallowing. Signs of
botulism include difficulty swallowing or breathing, slurred speech
and muscle weakness. Those symptoms can occur several hours after an
injection.
In a press release Wednesday, the FDA said patients should only
receive the drugs from health professionals who are licensed and
trained to administer them. Patients experiencing signs of botulism
should “seek immediate medical care,” the agency noted.
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