Investigation Update on Harmful Reactions Linked to Counterfeit "Botox"

CDC, several state and local health departments, and the U.S. Food and Drug Administration (FDA) are investigating reports of harmful reactions among people who received injections of counterfeit or mishandled botulinum toxin (commonly called "Botox").

As of May 8, 2024, a total of 15 people from 9 states have reported harmful reactions after receiving injections with counterfeit products, products from unverified sources, or from individuals who were not following state or local requirements. Investigation into the sources of these products is ongoing. More information about the counterfeit products may be found on FDA's website.

Note: Since the last update, 7 people from 2 states have been excluded from the investigation. During recent weeks, public health officials determined these people did not meet the criteria for inclusion in this investigation because they received injections with FDA-approved botulinum toxin and the individuals who administered the injections followed jurisdictional requirements. Undesirable effects are known to occur with use of FDA-approved botulinum toxin. These 7 people were reported to FDA through established mechanisms for monitoring the safety and efficacy of FDA-approved drugs.

The 15 people included in this investigation had reactions on dates ranging from November 4, 2023, through March 31, 2024. States reporting these reactions include California (2), Colorado (1), Florida (1), Illinois (2), Kentucky (1), New Jersey (1), New York (3), Tennessee (3), and Texas (1).

People reported experiencing

• Blurry vision and double vision
• Drooping eyelids
• Difficulty swallowing
• Dry mouth
• Slurred speech
• Difficulty breathing
• Fatigue
• Generalized weakness

Overall, 11 (73%) people were hospitalized and 6 (40%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Among 7 people tested for botulism, all had negative results.

All reports came from people identifying as female, ranging in age from 25 to 59 years, with a median age of 43 years. Thirteen (87%) people reported receiving botulinum toxin injections for cosmetic purposes.

CDC, several state and local health departments, and the U.S. Food and Drug Administration (FDA) are investigating reports of harmful reactions among people who received injections of counterfeit or mishandled botulinum toxin (commonly called "Botox").

As of April 18, 2024, a total of 22 people from 11 states have reported harmful reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas. Harmful reactions occurred on dates ranging from November 4, 2023, to March 31, 2024. States reporting these reactions include California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas, and Washington.

Public health and regulatory officials have found that some people received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.

People have reported experiencing

• Blurry vision and double vision
• Drooping eyelids
• Difficulty swallowing
• Dry mouth
• Slurred speech
• Difficulty breathing
• Fatigue
• Generalized weakness

Of 20 people with information available, 11 (55%) people were hospitalized and 6 (27%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Of seven people tested for botulism, six people had negative results. Results are pending for one person.

All reports came from people identifying as females, ranging in age from 25 to 59 years, with a median age of 41 years. Twenty (91%) people reported receiving botulinum toxin injections for cosmetic purposes. All people reported receiving these injections from unlicensed or untrained individuals or in non-healthcare settings, including homes and spas.