FDA Issues Alert for Counterfeit Botox Across Multiple U.S. States

The U.S. Food and Drug Administration (FDA) has issued an alert regarding counterfeit botulinum toxin that has been detected in several states. 

The agency issued a statement on April 16 noting that it is aware of the issue and is working with the Centers for Disease Control (CDC), state health departments, and manufacturers to protect the drug supply. According to the alert, the incidences in question "have occurred when counterfeit Botox is injected by licensed and unlicensed individuals and/or in non-medical or unlicensed settings. The products appear to have been purchased from unlicensed sources." Reports and health alerts were issued last week in Illinois regarding suspected coinferfeit botulinum toxins reported by several patients in the state.

"Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting one’s head following injection of these products," the Agency stated in a press release. "These symptoms are similar to those seen when botulinum toxin spreads to other parts of the body."

The FDA has also released the following information for use by consumers:

• If you are experiencing any of the symptoms listed above, following an injection of botulinum toxin products, contact a health care professional or go to the emergency room.
• Confirm with your health care professional that you are receiving a product from an authorized source.
• Ask your health care professional if they are licensed and trained to administer the product.

Signs of Counterfeit Versions of Botox

There are some similarities between the counterfeit Botox products and the FDA-approved product. AbbVie manufactures the authentic Botox products in 50-, 100- and 200-unit dose forms. The product descriptions on the outer cartons are either “BOTOX® COSMETIC / onabotulinumtoxinA / for Injection” or “OnabotulinumtoxinA / BOTOX® / for injection.” The manufacturer identified on the outer carton is either “Allergan Aesthetics / An AbbVie Company” or “abbvie.” FDA-approved Botox displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial.

Additionally, there is "no current indication that the reported events were linked to AbbVie’s FDA-approved Botox, and the genuine product should be considered safe and effective for its intended and approved uses," ther Agency said.

The counterfeit product includes counterfeiting of the outer carton and vial. A counterfeit product may be identified by one or more of the following:

• 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

Additional visual checks for counterfeit products are available here. Consumers are urged to report any suspected counterfeit Botox products to FDA at 800-551-3989, or to reach out at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm.

Source: FDA press release. Accessed April 16, 2024.