Three women developed neurologic symptoms following injections of an unapproved botulinum neurotoxin product at a Colorado medical spa, prompting a public health investigation that uncovered multiple injection safety violations. All 3 women recovered without hospitalization, although 1 sought outpatient medical care.
The findings, published October 8 in the Centers for Disease Control and Prevention (CDC)'s Morbidity and Mortality Weekly Report, followed a January 2026 report to Rocky Mountain Poison and Drug Safety from a woman who developed symptoms after receiving botulinum neurotoxin injections from a licensed medical provider.
Researchers from the Colorado Department of Public Health and Environment, CDC, US Food and Drug Administration (FDA), and local public health authorities examined the medical spa's injection practices, products, and patient outcomes. They surveyed 52 patients identified as having received injections between December 2025 and January 2026. Of the 27 who responded, 2 additional women reported symptoms.
All 3 women confirmed receiving the same botulinum neurotoxin product, which is approved in other countries but not by the FDA. None knew the product lacked FDA approval. The injections came from the same product lot and were administered in the upper brow, glabella, or upper lip, with reported doses of 24, 3, and 10 units.
The first patient reported numbness and tingling in her arms and legs, neck stiffness, dysphonia, headache, and blurred vision. The second patient experienced dysphonia, headache, and blurred vision. The third reported dyspnea, headache, and muscle weakness in her arms and legs. All 3 women reported symptoms following treatment. Only the first sought medical attention, and all subsequently recovered.
Although the manufacturer confirmed that the implicated lot number matched its records, the product from that lot was unavailable for testing. CDC testing of a different lot collected from the medical spa detected active botulinum neurotoxin type A but did not identify elevated toxin levels or contaminants.
The investigation also uncovered problems with how products were obtained, prepared, and stored. Inspectors found both FDA-approved and unapproved botulinum neurotoxin products at the facility. The provider reported purchasing the unapproved products through an online supplier.
Other violations included inappropriate use of a preservative-containing diluent, use of single-dose vials for multiple patients, inadequate temperature monitoring, and storage and use of reconstituted, unlabeled products past their beyond-use dates.
Researchers identified several possible explanations for the adverse events, including unknown product concentration, contamination, and improper preparation, administration, or storage. The investigation did not establish which, if any, contributed to the patients' symptoms.
The provider was ordered to immediately stop using unapproved products, and authorities filed a formal complaint with the Colorado Department of Regulatory Agencies. The provider subsequently reported discontinuing their use.
The CDC emphasized the importance of reporting adverse events following botulinum neurotoxin injections through FDA MedWatch and advised providers against purchasing or administering unapproved products from unauthorized suppliers.
