Silver Spring, Md., Nov. 05, 2025 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware of adverse events associated with unapproved and misbranded botulinum toxin products, including botulism symptoms.
Botulinum toxin products are injectable drugs that block nerve activity in muscles, temporarily reducing muscle movement. They are used for cosmetic purposes like reducing facial wrinkles as well as to treat medical conditions such as chronic migraines and muscle stiffness.
“Unapproved and misbranded Botox products carry serious health risks. Today we’re taking action to protect American consumers and prevent online entities from selling these dangerous products,” said FDA Commissioner Marty Makary, M.D., M.P.H.
FDA-approved botulinum toxin products carry a boxed warning, the agency’s most serious warning, indicating the drug carries a significant risk of serious or life-threatening side effects. The boxed warning indicates the product may cause symptoms of botulism, which attacks the body’s nerves and causes muscle weakness that can lead to difficulty breathing and even death.
There are several FDA-approved botulinum toxin products, such as Botox, which are only available with a prescription from a licensed health care professional. Patients should ensure they only receive these products from a provider who is licensed and trained to administer such injections. Additionally, patients should only receive these injections if the product is obtained from an authorized source. Products purchased from unauthorized sources may be unapproved, misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe.
Seek immediate medical care if you have symptoms of botulism, including trouble swallowing or breathing, after receiving a botulinum toxin product injection.
The FDA issued warning letters to:
- 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
Health care professionals and consumers should report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Related Information
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Contact Info
U.S. Food and Drug Administration
FDAPressAlerts@fda.hhs.gov
+1 202-690-6343
