Unapproved Med Spa Botox Tied to Adverse Events

Three women experienced neurological symptoms after injections of botulinum toxin at a medical spa in Colorado, which turned out to be an unapproved product, public health officials said.

All three had injections in the upper brow, glabella, or upper lip within a day of each other, and all experienced symptoms on the day of their injections — including numbness and tingling, muscle weakness, dysphonia, blurred vision, or neck stiffness, reported Pallavi Oruganti, DVM, of CDC’s Epidemic Intelligence Service, and colleagues in Morbidity and Mortality Weekly Report.

While those symptoms dissipated within a few days, none of the women knew the injections they received were not FDA approved, they reported.

Public health officials launched an investigation after the first patient reported the adverse effects to the Rocky Mountain Poison and Drug Safety (RMPDS) in January 2026. Her symptoms had started 5 days earlier, the same day she received the injection from the medical spa.

The symptoms she reported — numbness and tingling in her arms and legs, neck stiffness, dysphonia, headache, and blurred vision — improved by the time she reported them to RMPDS, and her primary care physician had determined that treatment wasn’t needed.

After that, the Colorado Department of Public Health and Environment (CDPHE) launched an investigation with the CDC, FDA, and the local public health agency. CDPHE visited the medical spa to collect product samples and evaluate the injection safety practices.

Investigators found both FDA-approved and not approved products on site.

This site assessment also revealed other issues, including “inappropriate use of a preservative-containing diluent, use of single-dose vials for multiple patients, inadequate temperature monitoring, and storage and use of reconstituted and unlabeled product past the beyond-use date,” the researchers reported.

Public health investigators then sent a text survey to patients who received the injections at the spa in December 2025 and January 2026. Of those 52 patients, 27 responded, revealing two more patients who experienced symptoms following their injections. One of them had dysphonia, headache, and blurred vision, while the other had shortness of breath, headache, and leg and arm muscle weakness. Neither had sought medical treatment for their symptoms.

All three patients who reported symptoms had received injections from the same lot of the non-FDA approved product.

The med spa was told to immediately halt using unapproved products and “a formal complaint against the provider’s license was submitted to the Colorado Department of Regulatory Agencies,” the researchers reported.

Potential causes for the symptoms included “unknown product concentration, product contamination, improper preparation, and improper administration or storage of the product,” they wrote.

Botulinum toxin should be purchased from authorized sources and administered by licensed providers, Oruganti and colleagues urged.

This isn’t the first instance of bootleg botulinum toxin products causing issues. Last year, the FDA sent warning letters to more than a dozen websites for selling unapproved and misbranded botulinum toxin products. In 2024, the CDC warned about counterfeit or mishandled botulinum toxin products making their way into the market. Both of these scenarios were tied to reports of adverse events.