Preliminary Conclusions and Actions
Licensed medical providers have safely administered FDA-approved BoNT for decades, despite its being one of the most potent naturally occurring toxins (2,3). However, unsafe use (e.g., use of counterfeit products, administration by unlicensed providers, or self-injection) has resulted in severe illnesses, with some patients requiring invasive mechanical ventilation and administration of BAT; no deaths have been reported (CDC, unpublished data, 2025). Health care providers should counsel persons interested in BoNT injections about risks associated with improper administration and encourage them to seek injections only from licensed, trained medical professionals operating in accordance with jurisdictional requirements and using FDA-approved BoNT. Misleading and inappropriate guidance from social media regarding self-injection of BoNT should be countered with information about the associated risks.
The illnesses described in this report are consistent with local and possible remote anatomic spread of BoNT, similar to previously reported cases that occurred after cosmetic injections of counterfeit or presumed counterfeit BoNT products (4). BoNT was not detected in the serum of any of the three patients, a common finding in all types of botulism (2). Possible reasons BoNT was not detected in these patients include 1) BoNT did not circulate in these patients’ bloodstreams, and their clinical features were the result of diffusion, rather than circulatory dissemination, of BoNT from where it was injected to nearby muscles; 2) BoNT was circulating in the patients’ bloodstream when the specimens were obtained but at levels below the assay detection threshold; or 3) BoNT that previously circulated in the patients’ bloodstream had already bound to synaptic receptors when the specimens were obtained. The 3-day to 4-day delay between symptom onset and collection of serum specimens could have precluded detection of BoNT that had previously been present. BoNT has been detected rarely in serum after cosmetic or therapeutic injection, with fewer than 10 such cases identified in the United States (CDC, unpublished data, 2025). It is unclear how beneficial BAT administration was in these three patients because there was no detectable BoNT for the BAT to bind to at the time of administration. The limited information provided by the patients about the products they used suggests that none were FDA-approved products; notably, all three patients reported purchasing BoNT online from vendors in Asia.
Medications, including BoNT, that are purchased from unlicensed sources such as online retailers might be misbranded, mislabeled or unlabeled, adulterated, counterfeit, contaminated, improperly stored or transported, ineffective, or unsafe¶ (5). Persons without a health care license should not purchase BoNT online and should only receive injections from a provider authorized to purchase and administer BoNT in their state. Although requirements for BoNT injection vary by state, patients can check with their local licensing boards or locate authorized providers through provider lookup tools available on FDA-approved BoNT product or professional organization websites. Health care providers should avoid purchasing BoNT from unlicensed sources. Warning signs that online pharmacies might be selling unsafe products include having an address outside the United States or selling damaged, mislabeled, expired, or deeply discounted products (FDA | Considering an Online Pharmacy?).
CDC offers a clinical botulism service (telephone: 770-488-7100) 24 hours a day to provide information for health care providers and health departments about diagnosing botulism and using BAT. FDA’s MedWatch program is available for reporting adverse effects from BoNT products, as well as possible counterfeit BoNT products (FDA | MedWatch Online Voluntary Reporting Form 3500).
