The FDA Warned About Fake Botox Sold Online. Here Is How to Know If Your Injections Are Safe — and What to Do If They Weren't.

What the FDA Found

In November 2025, the U.S. Food and Drug Administration sent formal warning letters to 18 websites that were selling what they advertised as botulinum toxin products — the class of injectable drugs that includes Botox, Dysport, Xeomin, and Jeuveau. The FDA found that the products being sold were either counterfeit, unapproved, or both: meaning they had not been reviewed by the FDA, had not passed safety and efficacy testing, and had not been manufactured under the quality controls that FDA-regulated biologics require.

The FDA linked the products sold by these websites to at least 22 documented adverse events, including cases in which patients developed symptoms consistent with botulism — a serious and potentially life-threatening illness caused by botulinum toxin spreading beyond the injection site and affecting muscles involved in breathing, swallowing, and other critical functions.

Counterfeit botulinum toxin products are particularly dangerous because they vary wildly in concentration, purity, and actual toxin content. A product that is more concentrated than labeled can cause widespread paralysis. A product that contains no active ingredient at all still carries the risks of injection — infection, vascular injury, embolism — with none of the intended effect. Both scenarios create real patient harm.

How to Verify Your Botox Is Legitimate

The safest starting point is simple: only receive botulinum toxin injections from licensed medical providers — physicians, nurse practitioners, physician assistants, or registered nurses working under direct physician supervision — operating in a regulated medical setting. In the United States, Botox Cosmetic and Botox (therapeutic) are manufactured exclusively by AbbVie (formerly Allergan). Dysport is manufactured by Ipsen. Xeomin is manufactured by Merz. Jeuveau is manufactured by Evolus. These are the only companies whose botulinum toxin products are FDA-approved for use in the US market.

To verify that the product you received is legitimate:

• Ask for the product name and manufacturer. Any legitimate provider should be able to tell you exactly which product was used and who manufactured it.
• Ask for the lot number. Every vial of FDA-approved botulinum toxin carries a lot number that can be traced to a specific manufacturing batch. If your provider cannot provide a lot number, that is a significant red flag.
• Verify the provider's license. Medical injectors should hold current licenses from their state's medical or nursing board. Most state licensing boards have online lookup tools where you can verify licensure status.
• Be cautious of unusually low prices. Botox Cosmetic has a relatively consistent wholesale price because AbbVie controls distribution. Prices that seem dramatically lower than market rate may indicate a diluted product, a counterfeit, or a product obtained through unauthorized channels.
• Do not purchase injectable products online for self-injection or to bring to an injector. No legitimate medical provider in the US purchases botulinum toxin through retail websites. Products sold online directly to consumers are not FDA-approved for this use.

Warning Signs of a Bad Injection or Counterfeit Product

If you received botulinum toxin injections and experience any of the following symptoms — particularly in the days following treatment — seek medical attention promptly:

• Eyelid drooping (ptosis) that extends beyond the treated area or is significantly more pronounced than expected
• Difficulty swallowing, chewing, or speaking
• Breathing difficulty or shortness of breath
• Widespread muscle weakness not limited to the injection site
• Vision problems, including double vision or difficulty moving the eyes
• Facial asymmetry that was not present before the injection, especially if worsening over time
• Signs of infection at the injection site: redness, warmth, swelling, discharge, or fever

Symptoms of botulinum toxin spreading beyond the injection site can appear hours to weeks after treatment. The FDA has issued a black box warning for all botulinum toxin products noting this risk, and the risk is substantially higher with products of unknown concentration or composition — which describes counterfeit products precisely.

Legal Options for Those Injured

If you were injured by a counterfeit or unapproved botulinum toxin product, several legal theories may apply depending on the specific circumstances of your situation:

• Product liability against the seller or distributor: If you received a counterfeit product, the entity that sold or distributed it — whether a website, a supplier, or a gray-market distributor — may be liable under product liability law for selling a defective and dangerous product. This applies even if they did not manufacture the counterfeit product themselves; sellers in the chain of distribution can be held strictly liable in most states.
• Medical malpractice against an unlicensed or negligent injector: If your injector was not properly licensed to administer injections, failed to verify the product's legitimacy, or failed to exercise reasonable care in sourcing and administering the product, you may have a medical malpractice claim. This includes cases where licensed providers knowingly used non-FDA-approved products.
• Personal injury: Even without a specific product liability or malpractice theory, a straightforward personal injury claim may be available if your injuries resulted from another party's negligence or intentional wrongdoing in connection with the injection.

What to Do If You Think You Received a Counterfeit Product

Taking the right steps immediately after discovering you may have been harmed protects both your health and your legal rights:

• Seek medical care immediately if you have symptoms. If you believe you may be experiencing botulism symptoms — breathing or swallowing difficulty — go to an emergency room. This is not a situation to manage at home or wait and see.
• Report to FDA MedWatch. The FDA's MedWatch program (accessible at fda.gov/safety/medwatch) collects adverse event reports. Reporting helps the FDA identify patterns and take enforcement action against additional bad actors. Your report may protect future patients.
• Document everything. Save any receipts, invoices, or communications with your provider. Photograph any physical symptoms if they are visible. Request a copy of your complete medical records from the treating provider, including the product name, lot number, and any intake documentation you signed.
• Preserve the product packaging if possible. If any vials, syringes, or packaging remains, do not discard it. This physical evidence can be tested by an independent laboratory to determine what the product actually contained.
• Consult a personal injury attorney. Attorneys who handle medical product liability and personal injury cases can evaluate whether you have a viable claim, identify the responsible parties, and assess what damages you may be entitled to recover — including medical expenses, lost wages, and pain and suffering.