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The FDA Sent Warning Letters to Over a Dozen Companies Selling Botox Knockoffs

Posted on June 28, 2025 by nktmhu

A hand wearing a ring holding up a syringePhoto: Vanessa GrandaSave StorySave this storySave StorySave this story

Just like we’ve come to casually call all tissues “Kleenex” and every lip balm “ChapStick,” the brand name “Botox” has become the catch-all term for botulinum type A, the injectable neuromodulator known for relaxing wrinkles. If you read Allure regularly, you probably already know that there are numerous FDA-approved iterations of the stuff— Botox, of course, plus Dysport, Xeomin, Jeuveau, Daxxify, and Letybo—which you’ll find in the kits of qualified injectors like dermatologists and plastic surgeons. No other neurotoxin brands have been reviewed or approved by the U.S. Food & Drug Administration, and some questionable companies are counting on patients and unqualified injectors not knowing this—or worse, not caring.

On November 5, 2025, the FDA issued warning letters to more than a dozen companies for “[introducing] into interstate commerce unapproved and misbranded injectable botulinum toxin drug products.” In other words, these companies—most of which are based in Korea but also include businesses in America, China, and Panama—are accused of selling injectable formulas that purport to be botulinum type A. These brands have names like Liztox, Toxsta, Botulax, and Wutox, none of which are FDA-approved.

Funny as you might find those names, the experts aren’t laughing. “Botulinum toxin type A is a powerful neurotoxin, and without controlled studies on diffusion, dosing, and systemic effects, unapproved versions can be harmful,” says Palm Beach-based board-certified dermatologist Leslie Baumann, MD. That harm, according to Connecticut-based board-certified dermatologist Mona Gohara, MD, can include infection, facial drooping, and even paralysis.

And the substances in question might not even be botulinum toxin at all. “They should be treated as mystery liquids,” says cosmetic chemist Kelly Dobos. “It's well known that these types of products are drugs and have a known degree of risk, so it's rather unscrupulous for companies to be marketing these products in this way.”

How the hell could “mystery liquids” end up in patients’ faces? As Dr. Baumann explains, only licensed doctors, physician assistants, nurse practitioners, and registered nurses are allowed to buy FDA-approved injectable treatments, which they purchase directly from manufacturers and distributors that are also approved by the FDA (plus, they usually have to complete training specific to the brand of neuromodulator they’re administering). Dobos says it’s unlikely that any reputable, medically supervised facility would be using products like the ones the FDA sent warning letters about. It’s more likely, she adds, that they’d be used for what she calls “backroom Botox” procedures happening in salons, boutiques, or even in people’s private homes.

Anyone who fancies themselves an injector can go through unofficial channels—like the online retailers on the receiving end of these FDA warnings—to get unvetted products. “People who do not have a valid license to purchase the legal products or those trying to cut costs may buy them,” Dr. Baumann says. Their clients either trust that their injector is using an FDA-approved product or haven’t considered the safety and efficacy of whatever their injector is using. “In my opinion, that shows little regard for patient safety, because these [unapproved brands] have not been shown to be safe or effective by the FDA,” Dr. Baumann adds.

If news like this is encouraging you to be especially diligent when seeking out treatments like Botox—as it should—there are ways to be sure the stuff going in your face is safe. One of the easiest: “Patients can always ask to see the [product] box,” Dr. Gohara says. “Real products have holograms, lot numbers, and expiration dates that match the vial.”

While the authenticity of the product itself is obviously very important, the skills and credentials of the injector are just as critical to the safety of injectable treatments. “Patients should only trust qualified, licensed injectors who use FDA-approved products and understand how to administer them safely,” says Dr. Baumann. The best way you can ensure that’s the case is to see a board-certified dermatologist or facial plastic surgeon. “Board-certified dermatologists and other qualified injectors understand anatomy, dosing, and safety. It’s artistry grounded in medical training,” Dr. Gohara says. They don’t just know where to inject, she says; they also know how what’s happening on the surface connects to your overall health.

But that’s if you’re lucky enough to have access to a doctor in your area. If that’s not feasible, there are other solutions: ask all injectors for their credentials to ensure they’re a highly trained medical professional, like a physician assistant, nurse practitioner, or registered nurse.

Each expert Allure spoke to expressed concern that extends beyond the existence of these unapproved products. “I worry that consumers in pursuit of convenience or a good deal may be unknowingly putting themselves at serious risk,” Dobos says. It’s a warning echoed by Dr. Gohara: “This isn’t a knockoff Chanel bag. The stakes are way higher.”

Category: HEALTHY-NUTRITION, STRETCH

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