FDA Drug Recalls and Warnings: Serious Risks of Unapproved Botox Injectables

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<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting warning letters sent to 18 companies for selling “unapproved and misbranded” botulinum toxin injectable drugs (“Botox” products) over the internet.</p>
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<p><a href="https://medlineplus.gov/botox.html" target="_blank" rel="noreferrer noopener">Botulinum toxin</a> injectable drugs work by temporarily blocking nerve activity in muscles, reducing muscle movement. The injections are used to temporarily improve the appearance of facial wrinkles as well as to treat medical conditions such as chronic migraines, excessive sweating (hyperhidrosis), muscle stiffness, and urinary incontinence. FDA-approved brand-name botulinum toxin products include Botox, Botox Cosmetic, Daxxify, Myobloc, and Xeomin.</p>
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<p>The FDA announced the warning letters in a <a href="https://www.fda.gov/news-events/press-announcements/fda-warns-companies-over-illegal-marketing-botox-and-related-products" target="_blank" rel="noreferrer noopener">news release</a> posted November 5, 2025, stating that the unapproved products have been associated with serious health risks, including botulism symptoms. FDA-approved botulinum toxin drugs are prescription-only and carry a boxed warning, which is the most serious kind of safety warning, about the risk of <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=485d9b71-6881-42c5-a620-a4360c7192ab" target="_blank" rel="noreferrer noopener">toxin effects</a> spreading to distant parts of the body from the injection site. The FDA advises that if you have symptoms of botulism, including trouble swallowing or breathing after receiving a botulinum toxin product injection, you should seek immediate medical care.</p>
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<p>Many of the websites receiving warning letters sell their products internationally and feature Korean aesthetic products, including Korean-made “dermal fillers.” Injectable dermal fillers are promoted as a treatment for improving the appearance of wrinkles. Some of the sites advise that injectables should be administered by a trained health professional. However, no prescription or special credentials are required to make a purchase.</p>
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<p>This report is prepared using the most recent information posted in the <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm" target="_blank" rel="noreferrer noopener">FDA’s Enforcement Reports Database</a> (for recalls), <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters" target="_blank" rel="noreferrer noopener">Warning Letters Database</a> (for warning letters), and<a href="https://www.fda.gov/industry/actions-enforcement/import-alerts" target="_blank" rel="noreferrer noopener"> Drug Imports Alerts Database</a> (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.</p>
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<p>Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:</p>
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<h3 class="wp-block-heading">Recalls (Enforcement Reports Database)</h3>
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<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”</p>
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<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
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<li>Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<h3 class="wp-block-heading">Warning Letters (Warning Letters Database)</h3>
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<p>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 working days. If the recipient does not believe that they are in violation of FDA regulations, they may reply with an explanation of their reasoning.</p>
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<p>In most cases, company responses to FDA warning letters are not made public. If the FDA verifies that a corrective action has been taken, it may issue a “<a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters" target="_blank" rel="noreferrer noopener">close-out</a>” letter. If a violation is not correctable or is not verified by the FDA, no close-out letter will be issued. Individuals interested in finding out the status of a warning letter may submit an <a href="https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request" target="_blank" rel="noreferrer noopener">FDA Freedom of Information Act Request</a>.</p>
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<h3 class="wp-block-heading">Drug Imports Alerts Database</h3>
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<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211" target="_blank" rel="noreferrer noopener">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99" target="_blank" rel="noreferrer noopener">unapproved new drugs</a>. The violation lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.</p>
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<h2 class="wp-block-heading">FDA Warning Letters: Online Sales of Unapproved and Misbranded Drugs over the Internet</h2>
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<h3 class="wp-block-heading">Company: Dermax Company, Ltd.</h3>
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<p><strong>Location</strong>: China<br><strong>Store Website</strong>: https://dermaxshop.com<br><strong>Warning Letter Date</strong>: November 3, 2025<br><strong>FDA Department Issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Types of Products Sold</strong>: Injectable botulinum toxin products for cosmetic and medical uses<br><strong>Type of Warning</strong>: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet<br><strong>FDA Warning</strong>: The website sells drug products that have not been FDA-approved. Because the product labels do not include adequate directions for safe and FDA-intended use, the products are considered to be “misbranded” under FDA regulations. This poses an inherent risk for consumers because the drugs do not carry the same assurances of safety and effectiveness as drugs subject to FDA oversight. What’s more, injectable drugs are particularly hazardous. By bypassing the body’s natural barriers, they give toxic ingredients or microbial contaminants direct access to the bloodstream, raising the risk of severe infection and life-threatening sepsis.</p>
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<p><strong>Required Actions</strong>: The website must cease selling unapproved and misbranded drugs. The company should review its websites, product labels, and promotional materials to ensure that it is not violating FDA regulations for any of its products offered for sale, not just the products specified in the warning letter.</p>
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<p>Within 15 days, the company must respond in writing to the FDA with a description of how it has addressed the violations. Alternatively, they must respond with an explanation, with supporting materials, if they do not believe they have violated regulations.</p>
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<p><strong>Potential Consequences</strong>: Failure to address the violations may result in legal action, including product seizure or an injunction. For non-U.S. companies, products that appear to be misbranded or unapproved new drugs may be detained or refused admission.</p>
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<p><strong>Link</strong>:<a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dermax-co-ltd-718712-11032025" target="_blank" rel="noreferrer noopener"> FDA Warning Letter<br></a>Read the warning letters for a complete description of violations.</p>
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<h3 class="wp-block-heading">Additional FDA Warning Letters</h3>
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<p>The following companies with websites selling unapproved and misbranded botulinum toxin products received similar FDA warning letters on November 3, 2025. The company name links to the FDA warning letter.</p>
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<p>Consumers should always verify that an online website selling medications is a licensed pharmacy. The FDA’s “<a href="https://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/besaferx-resources-consumers" target="_blank" rel="noreferrer noopener">Be Safe Rx</a>” page has advice on buying from an online pharmacy.</p>
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<p><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acecosm-718610-11032025" target="_blank" rel="noreferrer noopener">AceCosm</a> (acecosm.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aesthetic-essentials-limited-718707-11032025" target="_blank" rel="noreferrer noopener">Aesthetic Essentials Limited</a>  (aesthetic-essentials.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/celestapro-718613-11032025" target="_blank" rel="noreferrer noopener">CelestaPro</a> (celestapro.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cosmenic-718621-11032025" target="_blank" rel="noreferrer noopener">Cosmenic</a> (cosmenic.net)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cosmo-korea-11032025" target="_blank" rel="noreferrer noopener">COSMO KOREA</a> (cosmo-korea.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/derma-solution-11032025" target="_blank" rel="noreferrer noopener">Derma Solution</a> (derma-solution.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dermacare-dba-filler-outlet-718715-11032025" target="_blank" rel="noreferrer noopener">Dermacare dba Filler Outlet</a> (filleroutlet.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dermax-co-ltd-718712-11032025" target="_blank" rel="noreferrer noopener">Dermax Co., Ltd</a> (dermaxshop.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/elle-pharm-718713-11032025" target="_blank" rel="noreferrer noopener">Elle Pharm</a> (ellepharm.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/estaderma-718714-11032025" target="_blank" rel="noreferrer noopener">Estaderma</a> (estaderma.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glam-derma-11032025" target="_blank" rel="noreferrer noopener">Glam Derma </a>(glamderma.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glow-nest-beauty-718710-11032025" target="_blank" rel="noreferrer noopener">Glow Nest Beauty</a> (glownestbeauty.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glowface-11032025" target="_blank" rel="noreferrer noopener">Glowface</a> (glowface.store)<br>Korean Aesthetic dba Korean Fillers (koreafillerexperts.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/korean-aesthetic-dba-korean-fillers-718842-11032025-0" target="_blank" rel="noreferrer noopener">Korean Aesthetic dba Korean Fillers</a> (koreanfillers.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maypharm-718717-11032025" target="_blank" rel="noreferrer noopener">Maypharm</a> (maypharm.net)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meamo-11032025" target="_blank" rel="noreferrer noopener">Meamo</a> (meamoshop.com)<br><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mjs-medicals-11032025" target="_blank" rel="noreferrer noopener">MJS Medicals</a> (mjsmedicals.com)</p>
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