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News
Bootleg Botox strikes again. Three women at a Colorado medical spa developed neurological symptoms — including blurred vision, muscle weakness, and neck stiffness — after receiving injections of a botulinum toxin product not approved by the FDA. The spa has since been hit with a formal regulatory complaint and ordered to stop using unapproved products.
Bootleg Botox lands a Colorado spa in hot water
Three women developed transient neurological symptoms after receiving cosmetic botulinum toxin (BoNT) injections at a Colorado medical spa, according to a new CDC report in the Morbidity and Mortality Weekly Report. The injections — administered to the upper brow, glabella, or upper lip within a day of each other — used a product not approved by the FDA, though it is approved in other countries. Symptoms included numbness and tingling, muscle weakness, dysphonia, blurred vision, and neck stiffness, all of which resolved without hospitalization.
A subsequent investigation by the Colorado Department of Public Health and Environment, alongside the CDC and FDA, uncovered a host of additional safety violations at the spa — including use of single-dose vials on multiple patients, improper storage, and unlabeled reconstituted products past their use-by date. A survey of 52 patients who visited the spa revealed two additional symptomatic patients beyond the initial case.
By the Numbers
Why it matters: This case is part of a troubling pattern of adverse events tied to unapproved BoNT products entering the cosmetic market. Regulators are urging patients to verify that providers use only FDA-approved products from authorized suppliers — and reminding clinicians that purchasing from unauthorized sources carries serious legal and patient safety risks.
