FDA Warns of Botulism Risks from Illegal Botox Injections Sold Online

Unapproved Botox Products Sold Through 18 Websites Linked to Botulism Illnesses and Severe Health Complications

Botulinum toxin, commonly known under the brand name Botox, is one of the most widely used cosmetic injectables in the United States. While Botox has a long history of FDA-approved use when administered by licensed professionals, serious risks emerge when unapproved or counterfeit products are injected by unqualified individuals.

In a sweeping enforcement move, the U.S. Food and Drug Administration (FDA) issued warning letters to 18 online retailers accused of illegally selling unapproved and misbranded Botox products. These unauthorized products have been tied to multiple cases of botulism, a rare but life-threatening illness. Reports from the Centers for Disease Control and Prevention (CDC) confirmed that at least 22 individuals from 11 states were harmed between November 2023 and March 2024. Some required hospitalization after developing symptoms, including drooping eyelids, breathing problems, and muscle paralysis.

This development raises serious questions about consumer safety, proper oversight, and legal accountability. Victims harmed by these illegal injections may be entitled to financial compensation through personal injury claims.

What Is Botulism and How Does It Occur in Cosmetic Injections?

Botulism is a rare condition caused by exposure to botulinum toxin, a neurotoxic protein that can lead to muscle paralysis and, in severe cases, death. While Botox is a controlled form of this toxin, it must be manufactured under strict conditions and administered by trained medical professionals to remain safe.

When counterfeit or unapproved botulinum toxin products are injected, the toxin can spread beyond the intended area, entering the bloodstream or central nervous system. This can trigger serious symptoms, including:

• General muscle weakness
• Blurred or double vision
• Difficulty swallowing or speaking
• Drooping eyelids or facial sagging
• Respiratory failure
• Paralysis

These symptoms can begin as early as a few hours or up to several days after injection. If untreated, botulism can lead to long-term disability or fatal outcomes.

FDA Enforcement and Online Retailers Under Scrutiny

In April 2025, the FDA released a public safety notification identifying 18 online platforms accused of selling misbranded or counterfeit Botox products. These products were being distributed across the U.S. without FDA approval, often with misleading claims about their safety or origin. The websites targeted in the enforcement action included:

• acecosm.com
• aesthetic-essentials.com
• celestapro.com
• cosmenic.net
• cosmo-korea.com
• derma-solution.com
• dermaxshop.com
• ellepharm.com
• estaderma.com
• filleroutlet.com
• glamderma.com
• glowface.store
• glownestbeauty.com
• koreafillerexperts.com
• koreanfillers.com
• maypharm.net
• meamoshop.com
• mjsmedicals.com

These platforms often target consumers or unlicensed beauty technicians looking to obtain Botox at a discount. In many cases, the sellers offer bulk products without requiring prescription verification or proof of medical credentials, both red flags for regulatory agencies.

The FDA reminded the public that any botulinum toxin product sold without agency approval is illegal and may be contaminated, improperly stored, or falsely labeled.

Who Was Affected by the Illegal Botox Injections?

Between late 2023 and early 2024, 22 individuals across 11 states developed symptoms of botulism after receiving cosmetic injections tied to the counterfeit products. According to the CDC, the majority of these patients were women between the ages of 25 and 59.

Many of the injections were performed in non-medical settings, including private homes and unregulated spas. Out of the affected group, 11 patients required hospitalization, with some needing respiratory support and extended observation. The symptoms reported ranged from localized facial weakness to widespread muscle paralysis.

The investigation is still ongoing, but officials believe that the injuries could have been prevented if the patients had received only FDA-approved Botox administered by licensed professionals in clinical settings.

Why Counterfeit Botox Is Dangerous and Difficult to Detect

One of the key challenges in identifying counterfeit Botox is its outward appearance. Many unauthorized versions are made to look nearly identical to legitimate products, including packaging and labeling. Some are imported from overseas manufacturers with no regulatory oversight.

Unlike FDA-approved Botox, these products may:

• Contain incorrect dosages
• Be contaminated with harmful substances
• Lack of potency, causing incomplete muscle paralysis or unexpected effects
• Contain unknown ingredients that increase the risk of allergic or immune responses

Because of the delicate nature of botulinum toxin, improper storage or handling—such as exposure to high temperatures during shipping—can also make even authentic products dangerous.

Consumers often have no way of knowing the difference, especially when administered by individuals who are not trained to recognize or report product defects.

Legal Implications for Victims of Counterfeit Botox Injections

Victims who suffer health complications due to illegal Botox products may be able to file lawsuits against multiple responsible parties. Depending on the circumstances, liability may fall on:

• Online retailers who sold misbranded or counterfeit products
• Individuals or businesses that administered injections without a license
• Distributors who imported unauthorized versions of Botox
• Landlords or event spaces that hosted illegal injection parties

Victims may pursue personal injury claims or product liability lawsuits seeking compensation for:

• Medical expenses (hospitalization, emergency care, rehabilitation)
• Lost wages due to the inability to work
• Pain and suffering from physical and emotional trauma
• Permanent disfigurement or disability
• Wrongful death damages if a family member died from botulism complications

Time limits apply to these claims, so anyone injured should consult with a qualified legal team without delay.

What Consumers Should Do If They Suspect Harm from an Injection

If you or a loved one received a Botox injection and experienced any of the following symptoms, you may be dealing with botulism or a related injury:

• Drooping eyelids or uneven facial movement
• Trouble breathing, speaking, or swallowing
• Sudden muscle weakness
• Difficulty keeping your head upright
• Nausea or blurry vision

Patients experiencing these signs should go to the emergency room immediately and inform medical staff about any recent cosmetic injections. Early treatment can significantly improve outcomes and reduce long-term damage.

Those who believe they received unapproved or counterfeit Botox should preserve any packaging, receipts, or messages from the provider and avoid additional procedures until a medical review has been completed.

FAQs About Botox Lawsuits and Botulism Injuries

What is the FDA warning about Botox products?

The FDA issued warnings to 18 online retailers for illegally selling unapproved Botox products. These products have been linked to botulism-related illnesses and may pose serious health risks.

How does botulism occur from Botox injections?

Botulism can happen if botulinum toxin spreads beyond the injection site. Counterfeit or improperly administered products increase this risk by delivering inconsistent or excessive doses.

What are the symptoms of botulism from an injection?

Symptoms include drooping eyelids, facial muscle weakness, difficulty swallowing or breathing, and, in extreme cases, paralysis or death. Medical attention should be sought immediately if these symptoms appear.

Who is at risk?

Anyone receiving unapproved or counterfeit injections is at risk, especially when the injections occur outside of a licensed clinical setting. Most recent cases have involved women ages 25–59.

Can I sue if I was injured by counterfeit Botox?

Yes. Victims may pursue personal injury or product liability claims against those responsible for selling or administering the dangerous product.

What compensation might be available?

Lawsuits may cover medical bills, lost income, physical and emotional pain, and permanent disfigurement. Families of deceased patients may also pursue wrongful death claims.

What if I don’t know what product was used?

Medical records, photos, receipts, and communication with the provider may help investigators identify the source. Legal teams can also request records or file subpoenas to uncover more details.

How long do I have to file a Botox injury lawsuit?

Every state has its own statute of limitations. It’s best to speak with an attorney right away to preserve your legal rights and ensure evidence is documented.

Contact Parker Waichman LLP For A Free Case Review

If you or someone close to you experienced serious side effects after receiving a Botox injection—especially one outside of a medical facility or from an unknown provider—you may be entitled to compensation. Parker Waichman LLP is currently reviewing cases involving counterfeit and unapproved Botox linked to botulism and serious medical harm.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free, confidential consultation. Let our national legal team review your situation and help you pursue justice for your injuries. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.