Investigators found dangerously mislabeled toxin vials and alarming lapses in practitioner safety, revealing how an under-regulated cosmetic industry exposed patients to life-threatening paralysis.
Rapid communication: A local outbreak of iatrogenic botulism associated with cosmetic injections of botulinum neurotoxin-containing products, England, 2025. Image Credit: marevgenna / Shutterstock
In a recent rapid report published in the journal Eurosurveillance, researchers in the United Kingdom detailed the investigation of a localized outbreak of 25 cases of iatrogenic botulism in North East England, highlighting the rare yet severe risks of botulism from cosmetic injections, particularly those involving unlicensed or inaccurately labeled products administered outside regulated clinical environments.
The case-control study identified strong associations between the outbreak and two specific practitioners (p < 0.001), as well as the use of an unlicensed cosmetic product (p < 0.001). While causality could not be definitively established, laboratory testing of the seized product revealed its potency was approximately 85% higher than labeled, underscoring the dangers of poorly regulated cosmetic supplies and the need for strengthened safety standards.
Background
Botulism is a rare but serious (potentially fatal) paralytic illness caused by the bacterium Clostridium botulinum. Symptoms of botulism, occurring as a response to toxins produced by these bacteria, include severe weakness, blurred vision, strained speech, and, eventually, complete paralysis.
A growing body of literature identifies food-borne C. botulinum contamination as the most frequent source of the disease. However, other sources of botulism, including infant botulism and wound contamination-transmitted cases, are increasingly being studied for their often severe, hospitalization-inducing outcomes.
Iatrogenic botulism occurs when a purified form of botulinum neurotoxin (BoNT, the active ingredient in cosmetic products like Botox) is improperly administered or used in excessive (unsafe) doses during medical or cosmetic procedures. Recent studies have found that the toxin can spread systemically, causing descending paralysis that can manifest as drooping eyelids, blurred vision, difficulty swallowing, difficulty breathing, and, in severe cases, respiratory failure.
In England, botulism is classified as a notifiable disease, requiring clinicians to report any suspected cases to the UKHSA. In June 2025, the UKHSA was alerted to a cluster of nine patients in North East England presenting with symptoms of botulism after receiving cosmetic injections in residential or non-clinical settings. This alert triggered a multi-agency public health investigation, comprehensively detailed in the present report.
About the study
The present rapid report details the comprehensive outbreak investigation conducted by the UKHSA in collaboration with local councils and the MHRA. The investigation had three main components: (1) epidemiological surveillance, (2) a case-control study, and (3) an environmental investigation.
First, the epidemiological surveillance established an IMT to coordinate the North East England outbreak response, define a probable case, and track all individuals meeting the criteria. Notably, a probable case was described as an individual who received a cosmetic BoNT injection from a practitioner in North East England on or after 1 May 2025, developed at least one compatible symptom (such as difficulty swallowing, altered speech, or difficulty breathing) within four weeks, and was diagnosed with botulism by a healthcare professional.
Second, the team conducted a case-control study to identify specific risk factors. Specifically, 21 cases (positive, hospitalization-requiring botulism incidence) from one county were compared against 29 controls. Controls were defined as local residents who also had recent cosmetic injections but did not demonstrate any of the symptoms under investigation. Data of interest included factors such as which practitioner patients attended, what product they received, and the number of injections they received. Cases were also more likely to report receiving a greater number of injections than at their previous appointment (p = 0.029) and, in some instances, injections in four or more facial areas (p = 0.058).
Study Findings
The present study identified 25 cases (median age = 43 years) of iatrogenic botulism, with approximate symptom onset between May and June 2025. The majority of patients were female (88%), with common symptoms including blurred vision (92%), fatigue (92%), difficulty swallowing (88%), and difficulty breathing. All 25 patients attended a hospital emergency department, and 16 (64%) required treatment with botulism antitoxin. All patients survived.
Serum mouse bioassays conducted on three cases were negative, highlighting the diagnostic challenges in toxin confirmation for iatrogenic cases.
The case-control study findings suggest that cases were significantly more likely to have attended one of two specific practitioners, 'A' or 'B' (p < 0.001), and to have received an unlicensed product (cOR = 39.7; 95% CI: 3.8–5,480; p < 0.001). Cases also reported markedly lower practitioner compliance with basic safety standards. For example, none of the cases reported receiving a consent form or side-effect information, compared to over 80% of controls. Additionally, only 15% of cases reported hand hygiene, versus 76% of controls.
The environmental investigation seized an unlicensed BoNT-containing product, "Product X," that had been used by one of the implicated practitioners. The product was labeled as having a potency of 200 units/vial. However, laboratory testing revealed an estimated actual potency of 370 units/vial (95% CI: 327–419 units), approximately 85% higher than the labeled potency. The authors cautioned that potency values may vary by assay and manufacturer, so label comparisons should be interpreted carefully. This product was among thousands of unlicensed BoNT vials intercepted by UK authorities since 2023, reflecting a broader systemic issue.
Key Findings - North East England Botulism Outbreak (2025)
Eurosurveillance rapid report, iatrogenic cases linked to cosmetic injections
- 25 iatrogenic botulism cases, majority female (88 percent), median age 43. All attended emergency care, 16 received antitoxin, all survived.
- Unlicensed, mislabelled product, “Product X” labelled 200 units per vial, tested at ~370 units per vial (about 85 percent higher), obtained outside regulated channels.
- Strong associations with two practitioners, case-control analysis linked cases to Practitioners A and B and receipt of the unlicensed product (cOR 39.7; p < 0.001).
- Severe safety practice failures, 0 percent of cases reported receiving consent forms or side-effect information vs >80 percent of controls. Hand hygiene reported by 15 percent of cases vs 76 percent of controls.
- Non-clinical procedure settings, many injections occurred in residential locations, limiting oversight and sterile protocols.
- Diagnostic challenges, three serum mouse bioassays were negative, underscoring limits of laboratory confirmation in iatrogenic exposure.
- Regulatory signal, UK authorities seized >4,700 unlicensed BoNT vials since 2023, indicating broader systemic risk in cosmetic injectables.
Conclusions
The local outbreak detailed in the present report serves as a warning about the risks within a rapidly expanding cosmetic sector. Study findings linked North East England’s 2025 botulism outbreak to unlicensed, inaccurately labeled products administered by specific practitioners, highlighting multiple points of failure in practitioner oversight and product sourcing.
Rather than attributing causality solely to product potency, the authors noted that illness may have resulted from the product itself, the method of administration, or a combination of both. The episode underscores the importance of the UK’s planned licensing scheme to improve practitioner training, insurance standards, and product safety in the cosmetic injectables industry.
Journal reference:
- Jasperse, J., Wilson, K., Akbar, S., Hayden, I., Naseem, Q., Worthington, A., Coglan, A., Hewson, M., Young, A., Fang, M., Liu, Y., Darke, J., Wong, V., Godbole, G., & Hughes, G. J. (2025). A local outbreak of iatrogenic botulism associated with cosmetic injections of botulinum neurotoxin-containing products, England, 2025. Eurosurveillance, 30(39). DOI – 10.2807/1560-7917.es.2025.30.39.2500746. https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2025.30.39.2500746#html_fulltext