Counterfeit Botox blamed in 11-state outbreak of botulism-like illnesses

Dangerous counterfeit versions of botulinum toxin — better known as Botox — are being linked to an outbreak that has now sickened 22 people in 11 states, causing multiple hospitalizations, federal safety officials are warning.

In an alert issued Tuesday to clinicians, the Centers for Disease Control and Prevention on Tuesday said unsafe counterfeit versions of Botox had been administered by unlicensed or untrained individuals in non-healthcare settings, like homes or spas.

As of Thursday, 22 people with adverse effects had been reported in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York City, Tennessee, Texas and Washington, the CDC stated. The onset of symptoms ranged from Nov. 4, 2023, to March 31, 2024. 

People reported experiencing botulism symptoms including blurred or double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing and fatigue.

The Food and Drug Adminstration is working with Botox manufacturer AbbVie to identify, investigate and remove suspected counterfeit Botox products found in the U.S. Currently, there’s nothing to indicate the illnesses are linked to the company’s FDA-approved Botox, with the genuine product safe and effective for its approved uses, the FDA noted.

“In partnership with public health authorities, we have confirmed the security of our Botox and Botox cosmetic supply chain as well as the safety, quality, and efficacy of all products we manufacture and distribute,” AbbVie subsidiary Allergan told CBS MoneyWatch.

How to avoid counterfeit Botox

If you’re considering Botox for medical or cosmetic reasons, the CDC advises asking whether the provider, clinic or spa is licensed and trained to give the injections, and if the product is FDA approved and purchased from a reliable source. Some states have a look-up tool that can be used to check on licensing, according to the agency.

Those in doubt should not get the injection and those who experience symptoms of botulism should seek medical care or go to an emergency room immediately, the CDC said.

Approved for cosmetic use more than 20 years ago, Botox is a popular drug to smooth wrinkles and appear younger, with injections typically costing around $530, according to the American Society of Plastic Surgeons. The effects of a shot last three to four months on average, so additional shots are needed to remain wrinkle-free.

Federal officials have previously cracked down on unregulated Botox and other cosmetic treatments. In 2023, U.S. Customs and Border Protection officers in Ohio intercepted such fillers that had been shipped from Bulgaria, China, Korea and Spain.