Fake Botox Has Made People Sick in 9 States

Nine of the patients were hospitalized, and four were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site, the CDC said in an April 15 statement. Symptoms have included blurry and double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing, fatigue, and generalized weakness, the CDC said.

So far, reactions to fake or mishandled Botox have been reported in Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington, per the agency.

Botox Should Be Given Only by Trained Professionals

All but one of the patients reported receiving Botox for cosmetic reasons. Every patient got injections from an unlicensed or untrained person or in a non-healthcare setting — including homes and spas, the CDC said.

“Botulinum toxin should only be administered by licensed and trained providers, using recommended doses of FDA-approved botulinum toxin, preferably in a licensed or accredited healthcare setting,” says Michelle Waltenburg, DVM, MPH, a senior botulism epidemiologist with the CDC's Division of Foodborne, Waterborne, and Environmental Diseases.

Many state health departments, including some where reactions were reported, have online tools people can use to check whether a Botox provider and their healthcare facility is licensed.

“Your state might have a license lookup tool you can check to see if a provider or setting has the appropriate license,” Dr. Waltenburg says. “You can also ask if the product is approved by the FDA and obtained from a reliable source but, if in doubt, don’t get the injection.”

How to Spot Fake Botox

“The products appear to have been purchased from unlicensed sources,” the FDA said in the statement. “Medications purchased from unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe.”

Authentic Botox is made by AbbVie and should list the manufacturer on the carton as “Allergan Aesthetics / An AbbVie Company” or “abbvie,” the FDA said. Approved products are described on the packaging as “BOTOX® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX® / for injection.”

Packages of FDA-approved Botox will list the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. The only FDA-approved doses are 50-, 100-, and 200-unit doses, the FDA said.

The FDA said there are several telltale signs of a counterfeit product that may appear on packaging for fake Botox:

• The outer carton and vial contain lot number C3709C3.
• The outer carton displays the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.”
• The outer carton and vial indicates 150-unit doses, which is not a unit made by AbbVie or Allergan.
• The outer carton contains language that is not English.

Protecting Yourself Against Fake Botox

To avoid counterfeits, patients should insist on seeing all the packaging and observe clinicians when they prepare injections, says Andy Pickett, PhD, the director and founder of Toxin Science Limited.

“Patients should ask to see the product in the original box, unopened, when they arrive for treatment,” Pickett says.

Looking online for images of the original packaging before your appointment can help you spot legitimate products, Pickett adds. Many packages have anti-counterfeiting features such as holograms that will be missing from fake products.

In the clinic, patients can also ask to see their charts, and insist that the injector records the exact dosage of Botox, the batch number, and expiration date based on the information on the vial, Pickett says.

Some clinics may prepare Botox injections at the start of the day, before patients even arrive, Pickett says. They may do this to load syringes with the required amount of Botox for patients’ injections scheduled for later in the day.

“This is poor clinical practice,” Pickett says. “The patient should insist on seeing the product that they are going to be injected with, not a blank syringe full of who knows what liquid, and they should see the product being prepared in front of them.”