FDA: Adverse Events Linked to Counterfeit Versions of Botox

Counterfeit versions of Botox (botulinum toxin) have been identified in multiple states and have resulted in harmful reactions, according to the Food and Drug Administration.

As of April 12, 2024, 19 people have reported significant side effects linked to counterfeit Botox products or mishandled botulinum toxin in 9 states (Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington). These adverse events included blurred or double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, constipation, incontinence, shortness of breath, generalized weakness and difficulty lifting one’s head.

Of these 19 patients, 9 were hospitalized and 4 were treated with botulism antitoxin due to concerns over possible spread of botulinum toxin to other parts of the body. All of the affected individuals were females who received the injections in non-health care settings by untrained individuals who purchased the product from unlicensed sources.

The investigation, which includes the Centers for Disease Control and Prevention (CDC), state health departments, and manufacturers, is ongoing. At this time, health care providers are being asked to carefully inspect their product for any signs of counterfeiting before use. The FDA is working with AbbVie, the manufacturer of Botox, to identify and remove suspected counterfeit products from the US drug supply.

The authentic product includes the following features:

• Product descriptions on the outer cartons are either “BOTOX^® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX^® / for injection”;
• Manufacturer identified on outer carton as either “Allergan Aesthetics / An AbbVie Company” or “abbvie”;
• Outer carton and vial both display the active ingredient as “OnabotulinumtoxinA”; and
• Available in 50-, 100-, and 200-unit dose forms.

The counterfeit product can be identified by 1 or more of the following:

• Outer carton and vial contain lot number C3709C3;
• Outer carton displays the active ingredient as “Botulinum Toxin Type A”;
• Outer carton and vial indicate 150-unit doses; and
• Outer carton contains language that is not in English.

Health care providers who suspect systemic botulism should call their health department immediately for consultation and antitoxin release. Additionally, the CDC’s clinical botulism service can be reached at 770-488-7100.

Adverse events related to medication use should be reported to the FDA’s MedWatch program. Consumers who suspect they were administered counterfeit Botox should call the FDA at 800-551-3989 or submit the report here.