The U.S. Centers for Disease Control and Prevention (CDC) issued an official health alert advisory on Tuesday warning about reports of fake Botox injections that have landed some patients in the hospital.
Along with the U.S. Food and Drug Administration (FDA) and state and local health officials, the CDC said it is investigating a total of 22 cases across 11 states starting in Nov. 2023 through March 2024.
Cases have so far been reported in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York City, Tennessee, Texas and Washington — all affecting women between 25 and 59 years of age.
The women have experienced "adverse effects" after being injected with "counterfeit botulinum toxin," the alert said.
The injections were all given by "unlicensed or untrained individuals" or in "non-health care settings, such as homes or spas."
The women's reported symptoms included blurred vision, drooping eyelids, dry mouth, fatigue, slurred speech, generalized weakness and shortness of breath.
Of the 22 cases, 11 women were hospitalized.
None of the instances met the "case definition for botulism," the CDC noted.
No deaths have been reported.
Botulism is a "serious and sometimes fatal" illness that occurs when a toxin attacks the body’s nerves, according to the CDC.
Initial symptoms usually include muscle weakness around the eyes, face, mouth and throat — which could also spread to the neck, arms, torso and legs.
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Other symptoms can include blurred or double vision, difficulty breathing, trouble swallowing, drooping eyelids, slurred speech and difficulty moving the eyes.
It is possible for people to experience some of these symptoms without having botulism.
"What’s particularly concerning are the respiratory problems that some are experiencing," Dr. Salar Hazany, a certified dermatologist and reconstructive surgeon at Scar Healing Institute in Beverly Hills, told Fox News Digital.
"If the wrong patient begins having trouble with their breathing, it could be fatal."
Dr. Craig Lehrman, director of aesthetic surgery at The Ohio State University Wexner Medical Center, noted that fake Botox has been an issue since the early 2000s.
"Unfortunately, I treat several patients a year who have received non-approved injectables of things they are told to be safe — which ends up having serious consequences," he told Fox News Digital.
"It has mostly been linked to injections in settings such as someone's home or a poorly regulated med spa."
Botox is made from a specific type of Clostridium botulinum, a bacteria that produces paralysis in the muscles where it is injected, he said.
"The people receiving the presumed counterfeit Botox are suffering from an illness that is similar to botulism, caused by the same bacteria," he said.
There are strict safety criteria for the use and storage of Botox, and serious risks come with the injection of fraudulent or poorly managed products, Lehrman warned.
"Botulism can carry detrimental effects ranging from infection, to permanent deformity, to serious wound formation."
"Cosmetic injections should be an FDA-approved product, administered by licensed providers and in licensed settings," the CDC stated.
There has been a large increase in the number of people offering these services who are not board-certified in the fields of plastic surgery, dermatology or ENT, according to Lehrman.
"I would advise potential patients to do their research on the person who will be injecting them — and not just search for the cheapest option," he said.
"I would recommend going to a center that has rigorous standards of education and a track record of safety."
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In most cases, Botox injections are safe, according to experts.
"Laboratory-confirmed cases of systemic botulism occurring after cosmetic or therapeutic injections of botulinum toxin are rare," the CDC said in its statement.
Millions of injections are performed each year by licensed medical providers and have been shown to be safe when done in the correct manner, Lehrman added.
"Those considering Botox should research the background of the provider and make sure that the practice has not racked up a number of complaints," added Hazany.
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"Do not go to an unlicensed provider. If the offer seems too good to be true, it probably is."
Anyone who experiences botulism-like symptoms following an injection should seek medical attention, according to health officials.
Fox News Digital reached out to Abbvie (manufacturer of Botox) and the FDA requesting additional comment.
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