Three Colorado Women Developed Blurred Vision and Weakness After Unapproved Botulinum Toxin Shots at a Medical Spa
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The report, published in the CDC’s Morbidity and Mortality Weekly Report, found the spa had been using a product that is approved in other countries but not in the United States. None of the women knew the product lacked FDA approval when they received it.
For the many adults who get wrinkle-relaxing injections, the findings point to an important question to ask before treatment: is the product FDA-approved, and where did it come from?
According to the MMWR report, the investigation began in January 2026, when Rocky Mountain Poison and Drug Safety alerted public health officials about a patient who developed symptoms the same day she received an injection from a licensed provider at a Colorado medical spa. Her symptoms began about five days before the poison center was contacted.
The Colorado Department of Public Health and Environment led the investigation with CDC, FDA and the local public health agency. The report does not name the spa or the city or county where it operates.
State health officials sent text messages to 52 patients who had received botulinum toxin at the spa in December 2025 and January 2026, and 27 responded. That outreach identified two more women with symptoms. All three had received the same lot of the unapproved product, with injections in the upper brow, between the eyebrows, or the upper lip.
Symptoms started in less than 24 hours for each woman. The first patient had numbness and tingling in her arms and legs, neck stiffness, a hoarse or weak voice, headache, and blurred vision. The second had voice changes, headache, and blurred vision. The third had shortness of breath, headache, and weakness in her arms and legs.
Doses were small, ranging from 3 to 24 units. Botulinum toxin works by blocking nerve signals to muscles, which is why effects beyond the injection site can show up as vision, voice or breathing problems.
No one was hospitalized. The first patient saw her primary care provider, who decided treatment was not needed, and the other two recovered without seeking medical care.
Investigators found several problems at the spa beyond the unapproved product. Both approved and unapproved products were kept on site, single-dose vials were used for more than one patient, temperature monitoring was inadequate, and some reconstituted, unlabeled product was stored and used past its safe-use date. Staff also used a diluent that contained a preservative.
The provider told investigators the unapproved products were bought from an online supplier. The exact lot given to the three women was not available for testing. CDC tested a different lot from the spa and found active botulinum toxin type A, with no elevated toxin level and no contaminants.
That leaves the cause unconfirmed. The report authors listed possibilities including unknown product strength, contamination, improper preparation and improper storage or administration. The report did not label the product counterfeit, though it noted that products from unauthorized suppliers might be.
A public health order told the provider to stop using the unapproved products, and the provider reported doing so. A complaint was also filed with the Colorado Department of Regulatory Agencies, which oversees professional licenses. The report notes that in Colorado, giving non-FDA-approved products can be grounds for disciplinary action.
“Use of counterfeit or unapproved botulinum neurotoxin (BoNT) can result in serious illness,” the report authors wrote.
The Colorado cases echo a larger national investigation. In 2023 and 2024, CDC tracked 17 people in nine states, including one in Colorado, who had harmful reactions after injections of counterfeit or mishandled botulinum toxin. Thirteen were hospitalized, and six were treated with botulism antitoxin. All were women ages 25 to 67.
CDC closed that investigation but said it continued to receive reports of similar cases. Its advice was direct: “If in doubt, don’t get the injection.”
The FDA warned that counterfeit Botox had been found in multiple states, with warning signs including non-English text on the carton and the active ingredient listed as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.” MedicalDaily has also reported that counterfeit Botox injections sent people to hospitals this year.
Women seeking cosmetic treatments have made up all reported cases in these investigations. Risk appears greatest when a clinic’s product sourcing is unclear, as it was at the Colorado spa.
Patients can ask the injector which brand they are using, whether it is FDA-approved, and whether it was bought directly from the manufacturer or an authorized distributor. Asking to see the vial and packaging before treatment is reasonable. A price far below local rates can be a warning sign.
The report authors said people should be encouraged to seek treatment only from licensed providers using FDA-approved products. They also urged providers not to buy products from unauthorized sources.
Anyone who develops symptoms after an injection should contact a clinician and mention the treatment. The CDC lists botulism warning signs such as trouble swallowing, muscle weakness, double or blurred vision, drooping eyelids, slurred speech, and difficulty breathing. Botulism is a medical emergency, and trouble breathing or swallowing needs emergency care right away.
Reactions can also be reported to the FDA’s MedWatch program and to the national Poison Help line at 1-800-222-1222. The report shows that unapproved products can still reach licensed clinics, so checking the source remains a patient’s best protection.
What happened to the three Colorado women?
They developed symptoms such as blurred vision, headache, voice changes and weakness within 24 hours of injections of an unapproved botulinum toxin product at a medical spa.
Yes. All three recovered, and none was hospitalized.
The report describes it as unapproved, meaning it is approved abroad but not by the FDA. It was not shown to be counterfeit, and the cause of the symptoms remains unconfirmed.
It began in January 2026 after a poison center alert. The CDC report was published on October 8, 2026.
What symptoms should people watch for after an injection?
Watch for blurred or double vision, drooping eyelids, trouble swallowing or speaking, muscle weakness, and breathing problems. Trouble breathing needs emergency care.
How can I tell if my injector uses an approved product?
Ask for the brand name, ask whether it came from the manufacturer or an authorized distributor, and ask to see the packaging.
A public health order told the provider to stop using unapproved products, and a complaint was filed with Colorado’s licensing agency.
Reported by medicaldaily.com.
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