Seven women became ill after cosmetic botulinum toxin injections in February and March 2024, and four of them were hospitalized. Not one of the injections took place in a medical setting, and for at least four of the women the product was counterfeit Botox, according to a field report from the Centers for Disease Control and Prevention.
The report is two years old. It is worth an owner's attention now because the question it raised, where the product came from and whether the paperwork proves it, has since been put to a physician-supervised med spa.
Who wrote it and what kind of report it is
"Notes from the Field" is a short-format outbreak report in CDC's Morbidity and Mortality Weekly Report. This one ran on July 11, 2024, with Christine M. Thomas of the Tennessee Department of Health as first and corresponding author and 19 co-authors, most of them from CDC, the Food and Drug Administration, and health departments in Tennessee, New York City, Kentucky and Massachusetts.
It is a case series, not a study with a comparison group. Health department staff interviewed the patients and reviewed their medical records after clinicians in New York City and Tennessee reported illnesses in March 2024. We read the full text.
What the investigators found
New York City's health department identified three patients. Tennessee's identified four, one of them a Kentucky resident admitted to a Tennessee hospital. All seven were women aged 26 to 55, with a median age of 48, and their symptoms began between February 23 and March 7, 2024.
Every patient sought care. Four were admitted, two were monitored in intensive care, and none needed intubation.
Six of the seven injections were given in a residence and one at what the report's table calls a cosmetic spa.
The Tennessee cluster is the clearest. Three Tennessee residents and the Kentucky resident were injected in a home by a relative of one of them, a person who was not licensed to give the injections. FDA determined that the product used on those four was counterfeit.
How FDA knew is the detail a purchasing manager should read twice. The injector supplied photographs of the packaging, which claimed a 150-unit vial of Botox from a manufacturer that, the report says, makes only 50-unit, 100-unit and 200-unit vials. Ireland, the manufacturing location, was misspelled. And the batch number on the vial label belonged to a legitimate 100-unit batch that had expired in August 2017.
The three New York City patients had no link to one another or to the Tennessee group. An unlicensed injector was confirmed in one of those cases and suspected in the other two. Product information was not available for any of them, though one patient reported paying less than the U.S. wholesale acquisition cost and another said the product had been bought overseas.
What the authors say they could not establish
Plenty. The report's conclusions are labeled preliminary, and the authors write that the investigation "did not determine why these illnesses occurred." They offer possibilities only, among them counterfeit product that might be more potent or contain harmful additional ingredients.
Laboratory confirmation was thin. Specimens from two patients, collected about three weeks after symptoms began, tested negative for botulinum toxin, which the authors say was likely because of the delay. And no product information was available for the New York City patients.
One caveat is ours, not the authors': seven cases in two jurisdictions cannot say how common the problem is. CDC's later summary of the wider 2024 investigation, updated on December 17, 2024 and marked closed, counted 17 cases and 13 hospitalizations in nine states, with no deaths, and said the agency was still receiving reports of similar cases.
What it means for a licensed practice
The report stops there. What follows is our analysis, not the authors'.
Nothing in it describes a licensed med spa buying from an authorized distributor. But the facts that marked the Tennessee product as counterfeit were packaging and lot facts: a vial size the manufacturer does not make, a misspelling, a batch number that belonged to something else. A practice can check those at receiving. An inspector can check them against purchase records afterward.
On April 1, 2026, FDA sent a warning letter under the Drug Supply Chain Security Act to a med spa in Southlake, Texas. Holland & Knight, in an August 5, 2026 client alert, called it the agency's first such letter to a dispenser. The letter says FDA compared purchase records with patient dispensing records and determined that the practice "dispensed significantly more Botox units than documented purchases from AbbVie," the manufacturer.
For an owner, the cheap lesson is clerical. Invoices from an authorized source, lot numbers logged at receiving, and units administered that reconcile to units purchased are the records that answer the question this report raised in 2024.
Sources
- Thomas CM, McElroy R, Yackley J, Fill MA, Goonewardene D, Mackley C, Roth E, Ackelsberg J, Slavinski S, Habrun C, Hodge B, Rush C, Brown CM, Waltenburg MA, Bertling LH, McGorty M, Johnson R, Schaffner W, Jones TF, Dunn JR. "Notes from the Field: Illnesses After Administration of Presumed Counterfeit Botulinum Toxin in Nonmedical Settings — Tennessee and New York City, March 2024." MMWR Morb Mortal Wkly Rep 2024;73(27):609-611. doi:10.15585/mmwr.mm7327a3: https://www.cdc.gov/mmwr/volumes/73/wr/mm7327a3.htm (also at https://pmc.ncbi.nlm.nih.gov/articles/PMC11254346)
- CDC, "Harmful Reactions Linked to Counterfeit 'Botox' or Mishandled Botulinum Toxin Injections," updated December 17, 2024: https://www.cdc.gov/botulism/outbreaks/harmful-reactions-botox-injections.html
- FDA, Warning Letter to Pure Indulgence Aesthetics (Southlake, Texas), MARCS-CMS 723267, April 1, 2026: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pure-indulgence-aesthetics-723267-04012026
- Holland & Knight, "Medical Spa Compliance Under the Microscope," August 5, 2026: https://hklaw.com/en/insights/publications/2026/08/medical-spa-compliance-under-the-microscope



