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GenZStyle > Blog > Beauty > The FDA Sent Warning Letters to Over a Dozen Companies Selling Botox Knockoffs
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The FDA Sent Warning Letters to Over a Dozen Companies Selling Botox Knockoffs

GenZStyle
Last updated: November 10, 2025 1:28 pm
By GenZStyle
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The FDA Sent Warning Letters to Over a Dozen Companies Selling Botox Knockoffs
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Just as we casually refer to every tissue as “Kleenex” and every lip balm as “Chapstick,” the brand name “Botox” has become the generic term for Clostridium botulinum type A, an injectable neuromodulator known for smoothing wrinkles. After reading it allure You probably already know that there are a number of FDA-approved products that are regularly included in the kits of qualified injectors such as dermatologists and plastic surgeons, including Botox, Dysport, Xeomin, Jeuveau, Ducify, and Retivo. Other neurotoxin brands have not been reviewed or approved by the U.S. Food and Drug Administration, and some questionable companies rely on patients and unqualified injectors not knowing this, or worse, being indifferent.

November 5, 2025 FDA issued a warning letter More than a dozen companies[introducing] Unapproved and misbranded injectable botulinum toxin drug products are distributed in interstate commerce. ” In other words, these companies (most of which are based in South Korea, but also include companies from the United States, China, and Panama) are accused of selling injections purporting to be Clostridium botulinum type A. These brands have names such as Liztox, Toxsta, Botulax, and Wutox, but none of them are FDA-approved.

These names may be funny, but experts aren’t laughing. “Botulinum toxin type A is a potent neurotoxin, and without controlled studies on dispersion, dosage, and systemic effects, unapproved versions can be harmful,” says the Palm Beach-based board-certified dermatologist. Leslie BaumanMD. According to a Connecticut board-certified dermatologist, the harm is Mona GoharaMD may include infection, facial droop, and even paralysis.

And the substance in question may not be botulinum toxin at all. “They should be treated as mystery liquids,” says cosmetic chemist Kelly Dobos. “It’s pretty unscrupulous for companies to market these products in this way because it’s well known that these types of products are drugs and carry some degree of risk.”

How on earth could a “mysterious liquid” end up on a patient’s face? Dr. Bauman explains that only licensed physicians, physician assistants, nurse practitioners, and certified nurse practitioners can purchase FDA-approved injectable therapies, as well as directly from FDA-approved manufacturers and distributors (in addition, they are typically required to complete training specific to the brand of neuromodulator they are administering). Dobos says a reputable, medically supervised facility is unlikely to use a product that the FDA has sent a warning letter to. She added that they will likely be used in what she calls “backroom Botox” procedures performed in salons, boutiques and even private homes.

Source: Allure – www.allure.com

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