A Colorado medical spa is facing a formal regulatory complaint after three women developed transient neurological symptoms following injections of a botulinum neurotoxin (BoNT) product that was not FDA-approved. The product — approved in other countries but not the U.S. — was purchased through an online supplier. The case, published in the CDC's Morbidity and Mortality Weekly Report, was first flagged in January 2026 when one patient reported symptoms to Rocky Mountain Poison and Drug Safety.

A joint investigation by the Colorado Department of Public Health and Environment (CDPHE), CDC, and FDA uncovered a range of safety violations at the spa: improper diluents, reuse of single-dose vials across multiple patients, inadequate temperature monitoring, and use of reconstituted products past their expiration dates. A text survey of 52 patients identified two additional affected individuals, all of whom had received injections from the same unapproved product lot.

Key Takeaways:

• Patients should verify that their provider uses FDA-approved BoNT products sourced from authorized distributors
• A medical license alone does not guarantee safe care — proper training, sourcing, and storage protocols are equally critical
• This is part of a broader pattern: the FDA issued warning letters to 18 websites selling unapproved BoNT in 2025, and similar adverse event clusters were reported in Tennessee and New York City in 2024

Why it matters: The growing market for discounted cosmetic injectables is creating real patient safety risks. This case is a reminder that cutting corners on sourcing and handling injectable products can have serious clinical consequences — for patients and providers alike.