Key takeaways:
Botox and Botox Cosmetic (onabotulinumtoxinA) are injectable medications. Botox Cosmetic treats facial wrinkles. And Botox treats several health conditions, such as bladder and muscle problems.
As of April 2024, several people have reported receiving counterfeit Botox injections. This has led to severe side effects in some people, including cases that required hospitalization.
If you receive Botox injections in a non-healthcare setting, or from someone who isn’t licensed or trained, you have a greater risk of receiving fake Botox.
Anytime you’re receiving Botox, ask the person administering it whether they’re licensed and trained to give Botox injections. Additionally, ask them if they received the product from a legitimate, authorized source.
Report suspected use of counterfeit Botox to the FDA. You can do this by calling 800-551-3989 or filing a report through their website.
Save on related medications
As of April 2024, counterfeit versions of Botox Cosmetic and Botox (onabotulinumtoxinA) have appeared in several U.S. states. Some of these incidents have resulted in serious health problems, with several people being hospitalized after receiving an injection of fake Botox.
For those who rely on Botox to treat a health condition, such as certain bladder and muscle problems, or if Botox Cosmetic is your go-to for treating facial wrinkles, this news might be alarming. But we’re here to help.
Below, we’ll discuss what to ask your healthcare professional (HCP), and how to spot counterfeit Botox, so you can feel safe and confident about your treatment.
In this article, we’ll refer to Botox Cosmetic and Botox as just “Botox” in most cases.
How can you tell real Botox from fake or counterfeit Botox?
Counterfeit Botox and real, FDA-approved Botox can be hard to tell apart. But there are a few notable differences that may indicate you’re receiving (or administering, if you’re an HCP) a counterfeit Botox product. We’ll point these differences out below, but if you’re ever in doubt, you can contact the manufacturer at 800-832-1925.
Signs of real Botox
There are a few ways to tell a real Botox product versus a counterfeit Botox product. Often, this involves looking at the label.
Since Botox is given as an injection into a muscle (called an intramuscular injection), it's only meant to be administered by an HCP. So you may not always have the chance to see the label. But you can ask your HCP to check for the signs that confirm the product they have is real Botox. These signs include:
Number of units: FDA-approved Botox Cosmetic only comes in 50 unit and 100 unit vials. Botox only comes in 100 unit and 200 unit vials. If your product has a different amount of units written on the box or vial, it’s not a real Botox product.
The box label: For Botox Cosmetic, the label should read “BOTOX® COSMETIC." Underneath, it will say “onabotulinumtoxinA for injection.” For a Botox product, it will say “OnabotulinumtoxinA." Underneath, it will say “BOTOX for injection.”
The manufacturer: Allergan is the manufacturer for real Botox. FDA-approved Botox will either have “Allergan Aesthetics, an AbbVie company” or simply “abbvie” written on the packaging. They also have a holographic “Allergen” image on the vial.
The active ingredient: On both the label of the box and label of the vial, the active ingredient “onabotulinumtoxinA” should appear.
Signs of counterfeit or fake Botox
Counterfeit Botox may contain one or more of the signs below:
The lot number C3709C3 may be listed on the box or on the vial itself
The box containing counterfeit Botox may list “Botulinum Toxin Type A” as the active ingredient (instead of onabotulinumtoxinA)
The box and vial may indicate that it contains 150 units (remember that real Botox products only come in 50, 100, and 200 unit vials)
The outer carton uses language besides English
The vial doesn’t contain the holographic “Allergan” image
Cost of Botox: Find out how much Botox costs and whether insurance covers it.
Botox alternatives: One treatment, Xeomin (incobotulinumtoxinA), works similarly to Botox to treat wrinkles. Learn about their similarities and differences.
Other wrinkle treatments: Learn about several other medications, products, and procedures that can prevent or treat wrinkles.
What are the risks of counterfeit Botox?
There have been reports of harmful side effects from counterfeit Botox. These reports appear to be from people receiving Botox products obtained from unlicensed sources. You may be more likely to encounter these products if you receive Botox in non-healthcare settings, such as in a home or at a spa.
Counterfeit Botox products may be contaminated, stored incorrectly, or contain a different amount of Botox than what’s listed on the label. Side effects reported from counterfeit Botox include:
Vision problems, such as blurry or double vision
Droopy eyelids
Dry mouth
Trouble swallowing
Slurring words
Trouble peeing
Constipation
Weakness and fatigue
Difficulty lifting your head
Shortness of breath
Side effects like these often suggest that the active ingredient in Botox (onabotulinumtoxinA) has spread to other parts of the body. This is called botulism.
Real Botox from Allergan (an AbbVie company) is considered safe and effective when administered correctly. Severe side effects from legitimate Botox products rarely occur.
What should you do if you think you’ve received counterfeit Botox?
If you think you’ve received counterfeit Botox, contact your HCP right away. You should also report the incident to the FDA at 800-551-3989, or file a report through their website. If you’re an HCP and you think you’ve administered counterfeit Botox, it’s important to notify anyone who may have been affected.
If you’ve had side effects from Botox, even if you don’t think it’s a counterfeit product, you should also report this to the FDA's MedWatch Program. This is a program where HCPs and members of the public can report side effects from medications, medical devices, and more. You can complete a report online using the MedWatch Online Voluntary Reporting Form, or download and complete the form and mail or fax it in.
If you experience severe symptoms like shortness of breath, difficulty swallowing, or severe muscle weakness after receiving a Botox injection — whether you know if it’s counterfeit or not — seek emergency care. Call 911 or have someone take you to the nearest emergency room.
How to avoid counterfeit Botox
The best way to protect yourself from counterfeit Botox is to make sure you’re receiving it in a healthcare setting from someone who is trained and licensed. Anytime you’re considering a Botox injection, ask the following questions:
Is the professional administering your Botox injection licensed and trained to give Botox? (Only medical professionals — such as physicians, nurse practitioners, or physician’s assistants — can administer Botox.
Is the Botox product you’re receiving an FDA-approved product?
Is the Botox product you’re receiving from a reliable, authorized source?
If the answer to any of these questions is “no,” don’t accept a Botox injection. And report the suspected use of counterfeit Botox to the FDA by calling 800-551-3989 or filing a report through their website.
If you’re an HCP administering Botox injections, make sure to purchase your products from licensed, legitimate sources. As mentioned above, real Botox from Allergan is safe and effective when it’s administered properly. Be sure to inspect the product you receive before administering it. If you think your Botox might be fake, don’t administer it.
The bottom line
Botox and Botox Cosmetic (onabotulinumtoxinA) are intramuscular (administered into a muscle) injections. Botox Cosmetic treats facial wrinkles and Botox treats several health conditions, including bladder and muscle problems. As of April 2024, counterfeit Botox products have been used in several states in the U.S., leading to severe side effects in some people. Some people have even been hospitalized.
If you receive Botox injections from someone who isn’t licensed or trained, or if you receive them in a non-healthcare setting, you run the risk of receiving counterfeit Botox. So anytime you’re receiving a Botox injection, ask the person administering it if they’re licensed and trained to give Botox injections. You should also ask them if they received the product from a legitimate, authorized source. If they can’t answer these questions, don’t receive the Botox injection. Report suspected use of counterfeit Botox to the FDA by calling 800-551-3989 or filing a report through their website.
Why trust our experts?
References
Allergan, Inc. (2023). Botox cosmetic- onabotulinumtoxina injection, powder, lyophilized, for solution [package insert].
Allergan, Inc. (2023). Botox- onabotulinumtoxina injection, powder, lyophilized, for solution [package insert].
Centers for Disease Control and Prevention. (2024). Harmful reactions linked to counterfeit “botox” or mishandled botulinum toxin injections.
Edwards, E. (2024). Fake Botox is the cause of bad reactions in 9 states, FDA says. NBC News.
Gibson, K. (2024). Counterfeit Botox blamed in 9-state outbreak of botulism-like illnesses. CBS News.
MedAesthetics Training. (2017). Who can perform botox and dermal filler procedures?
U.S. Food and Drug Administration. (2024). Counterfeit version of botox found in multiple states.
U.S. Food and Drug Administration. (2024). MedWatch: The FDA safety information and adverse event reporting program.
