Presumed Counterfeit Botox Given Outside Clinics: 7 Women Ill in Tennessee and NYC, 2024

Botulinum neurotoxin (BoNT) products are considered safe for cosmetic use when given in a clinical setting, though the toxin can spread around the injection site and cause local, short-lived nerve effects such as ptosis or diplopia.

In March 2024, clinicians told the New York City Department of Health and Mental Hygiene and the Tennessee Department of Health about people who had fallen ill after what were presumed to be cosmetic BoNT injections. A multistate investigation, joined by the FDA and CDC, set out to describe the illnesses and find the products.

CDC's visual summary of the report.

The patients

Health department staff interviewed patients and reviewed medical records, shared product information with the FDA, and Tennessee's state laboratory tested patient specimens for the toxin.

• Seven patients, all women, aged 26–55 (median 48): three found by New York City and four by Tennessee — one of them a Kentucky resident admitted to a Tennessee hospital.

Signs and symptoms (patients could have several):

The first sign was ptosis for five women, diplopia for three, headache or weakness for two each, and blurred vision for one.

• Where on the body: every woman was injected in the face (the forehead or glabella); some also in the neck, and one each in the trapezius and the axillae.
• Where it happened: six in a home, one at a cosmetic spa.

Where the product came from

Tennessee and Kentucky. The four women were injected at a home by a relative of one of them, who was not licensed to give such injections. From the photographs that person supplied, and after contacting the manufacturer, the FDA found the product counterfeit:

• the box claimed 150 units of "Botulinum Toxin Type A" (brand name Botox), but the maker produces only 50-, 100- and 200-unit vials;
• the Irish manufacturing site was misspelled;
• the batch number, C3709C3, belonged to a genuine 100-unit batch that expired in August 2017.

New York City. The three women had no link to one another or to the Tennessee cases. Each was injected in a different nonmedical setting — by an unlicensed person in one case for certain, and probably in the other two. No product details were available, but one paid less than the U.S. wholesale price, and another said the product had been bought overseas.

No antitoxin. CDC's Botulism Consultation Service advises clinicians and releases antitoxin when needed. It did not here: some patients' symptoms matched the toxin's short-lived effects or were no longer progressing, and for every patient more than 10 days had passed since symptoms began — by then the toxin is unlikely to be in the blood, so antitoxin would help little.

What it means

The illnesses fit local, and possibly more distant, spread of the toxin after presumed counterfeit product was injected by unlicensed people outside medical settings. Severe and potentially fatal illness from unlicensed products and off-label use has been reported before.

The investigation could not say why these women fell ill. Possible reasons: counterfeit toxin, which may be stronger or contain harmful added ingredients, or some people being more susceptible to the toxin. More study is needed of the range of effects cosmetic injections can have.

What to do

• Anyone getting injections: only from licensed, trained providers, using recommended doses of FDA-approved products — preferably in a licensed or accredited health care setting.
• Clinicians: ask patients with botulism symptoms about recent BoNT injections, and if botulism is suspected, contact the state or local health department at once.
• Health departments: investigate reports of possible botulism, consult CDC about antitoxin where indicated, and alert other federal agencies so that counterfeit products are found and taken off the market.

Symptoms of botulism can include ptosis, blurred and double vision, voice changes, dry mouth, drooling or pooling of secretions, dysphagia, shortness of breath, muscle weakness and fatigue. The most severe are descending paralysis and respiratory failure.

Sources

Based on Thomas CM, McElroy R, Yackley J, et al., "Notes from the Field: Illnesses After Administration of Presumed Counterfeit Botulinum Toxin in Nonmedical Settings — Tennessee and New York City, March 2024," MMWR Morbidity and Mortality Weekly Report, volume 73, Centers for Disease Control and Prevention; a work of the United States government in the public domain. The report's table counts three women injected in the neck although its Tennessee and New York columns add to two, so no neck count is given here; it also gives one of four Tennessee first symptoms as "100%", so first symptoms are given as counts only.