Harmful Reactions Linked to Counterfeit “Botox” or Mishandled Botulinum Toxin Injections

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.

More information about the counterfeit products, including signs of counterfeit versions, may be found on FDA’s website.

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.

If you are considering an injection of botulinum toxin for medical or cosmetic reasons (such as for wrinkles):

• Ask your provider and setting (such as clinic or spa) if they are licensed and trained to give the injection.
  • Your state might have a license look-up tool where you can check if a provider or setting has the appropriate license.
• Ask if the product is approved by FDA and obtained from a reliable source.
• If in doubt, don’t get the injection.

See your healthcare provider or go to the emergency room immediately if you have any symptoms of botulism, including

• Blurry or double vision
• Drooping eyelids
• Difficulty swallowing
• Difficulty breathing
• Muscle weakness

• Consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site.
  • If systemic botulism is suspected, call your health department immediately for consultation and antitoxin release. If no one answers, contact the CDC clinical botulism service 24/7 at 770-488-7100.
  • Refer to your state or local health department for guidance on reporting adverse effects.
• Counsel patients who report using or being interested in using botulinum toxin about the risks of botulism and potential adverse events.
• Encourage patients to receive injections only from licensed providers who are trained in proper administration of FDA-approved botulinum toxin, preferably in a licensed or accredited healthcare setting.

• FDA: Counterfeit Version of Botox Found in Multiple States