International food safety event: Infant formula and products containing arachidonic acid oil contaminated with cereulide toxin - Multi-country

Multi-country recalls of infant formula and other products have been initiated after cereulide toxin, was detected in batches of multiple internationally distributed brands. Investigations have identified arachidonic acid (ARA) oil, used as an ingredient in the implicated products, as the source of contamination. However, the full root cause analysis and complete traceability of all affected batches remains under investigation. Contaminated formulae, nutritional products, and oil mixes have been distributed to 99 countries and territories across six WHO Regions, with the first product recalls initiated on 10 December 2025. Between 1 January and 25 February 2026, 144 suspected and confirmed cases were reported across ten countries in three WHO Regions, with investigations ongoing. Based on the available information, WHO assesses the overall public health risk as moderate due to the vulnerability of the affected population (infants), the ongoing uncertainty regarding the full extent of distribution and exposure, and remaining gaps in case detection and root cause information.

Since 10 December 2025, and as of 25 February 2026, 99 countries and territories have been identified as having received batches of infant formula products subject to recall due to contamination with cereulide toxin. During this period, 144 suspected and confirmed cases were reported across 10 countries. The epidemiological investigations and product‑traceback activities remain ongoing in many countries.

The case definitions in use by the International Food Safety Authorities Network (INFOSAN) are currently:

Suspect case: A person presenting symptoms of cereulide intoxication with a history of consumption of the recalled product, without laboratory confirmation in a clinical sample.

Confirmed case: A person presenting symptoms of cereulide intoxication with a history of consumption of recalled product, with laboratory confirmation in a clinical sample.

Health authorities are actively searching for cases and conducting laboratory testing of human specimens and infant formula products. However, case definitions used may differ from those established by INFOSAN, such as those established by the European Centre for Disease Prevention and Control, creating challenges with comparability of reported case numbers.

Since this is not a routinely tested contaminant or condition, diagnostic challenges and limited surveillance capacity are hindering Member States’ ability to identify confirmed cases. One country has laboratory confirmed cases linked to the contaminated products (Belgium).

The limited case numbers appearing in multiple, geographically separated areas is consistent with sporadic exposures to contaminated products that were widely distributed.

​Precautionary recalls have been issued across all countries and territories where products were distributed. These measures aim to prevent further exposures, although the speed and completeness of product recall and withdrawal vary by location according to various factors including inspection and enforcement capacities. 

Cereulide is a heat-stable toxin produced by certain strains of Bacillus cereus, a Gram-positive, spore-forming bacterium ubiquitous in soil, dust, and food production environments. The primary hazard in this event is suspected to have occurred during the production of ARA oils used in infant formula, although a root cause analysis has not yet been provided to WHO. 

Cereulide is not contagious; illness occurs only when a person ingests the toxin, such as through consumption of contaminated products. The toxin withstands cooking temperatures (stable up to 121°C) and common pasteurization, persisting in finished products. Symptoms manifest rapidly, typically within 0.5–6 hours post-ingestion, and usually present as acute gastrointestinal symptoms (nausea, vomiting, abdominal pain) with risk of rapid dehydration and electrolyte imbalance which can be particularly severe in infants due to their physiological vulnerability and limited reserves. The toxin has a very low symptomatic dose threshold and remains fully active despite gastric conditions, contributing to its clinical potency. For babies who rely entirely on formula, repeated feedings can increase the amount of toxin consumed, and using contaminated formula for rehydration can worsen illness.

The absence of specific antidotes or targeted therapies places greater emphasis on supportive clinical care, effective risk communication to caregivers and health workers, and robust coordination between food safety and public health authorities. Where there is limited access to health care and where there may be delays in care seeking, rapid dehydration and electrolyte imbalance in infants may be fatal.

As of 25 February 2026, the following countries have notified suspected cases: Austria (9), Brazil (5),  China, Hong Kong SAR, (1), Czechia (4), France (11), Italy (1), Singapore (3), Spain (41), and the United Kingdom of Great Britain and Northern Ireland (61).  In other countries, including Denmark (32) and the Netherlands (221) the number of suspected cases is based on self-reporting and is therefore not comparable with the INFOSAN case definition.  To date, Belgium is the only country with laboratory‑confirmed cases, reporting eight confirmed intoxications linked to the implicated products.

WHO assesses the overall public health risk associated with this event to be Moderate. This assessment is based on the information currently available and reflects the wide international distribution of contaminated products, ongoing uncertainties regarding the full extent of contaminated product distribution, case detection, and root cause of contamination, and the vulnerability of infants and young children to dehydration and electrolyte imbalance from with vomiting illness associated with cereulide toxin ingestion.

Several considerations contribute to this assessment:

• Cereulide is a thermostable emetic toxin that can cause acute vomiting and rapid dehydration particularly in very young infants which can have severe consequences if untreated; mild or self-limiting cases are likely to go unreported, especially in settings with limited healthcare access or diagnostic capacities.
  
• The extent of the contaminated ARA oil distribution remains uncertain, as complete traceability from the original implicated manufacturer has not been provided to WHO. 
  
• Secondary distribution through commercial supply chains has further complicated efforts to identify all affected products. Additional investigation is required to determine the source and extent of the cereulide contamination. 
  

The international spread of contaminated products has already disrupted trade and supply chains across at least 99 countries and territories, with the possibility of further recalls if additional affected batches or product categories are identified. These recalls, while essential for public health protection, have created a risk of localized shortage of infant formula, particularly in settings where reliance on specific products is high, despite manufacturers’ efforts to increase production of unaffected products. A residual risk of exposure persists while investigations and traceability efforts continue, as competent authorities manage evolving distribution information and update risk communication measures. 

Mild clinical presentations can resemble common childhood illnesses, laboratory capacity for cereulide testing in contaminated products or human samples varies widely, and variations in case definitions across countries complicate consistent reporting and may delay detection. 

Although limited numbers of suspected and confirmed cases have been reported to date, without continued investment in surveillance for toxin‑related events, strengthened laboratory networks, training of health‑care providers, and clear communication on recalls and safe alternatives, delays in detection and response could lead to preventable morbidity in infants.

Based on the information available, WHO recommends Member States to maintain epidemiological surveillance, enhance readiness of laboratory capacity for cereulide testing of suspected contaminated products and in clinical samples of suspected cases, and facilitate effective implementation of recalls and withdrawals, as needed.

WHO advises Member States to:  

• Identify, trace, and withdraw all affected products from the market.
• Verify the effectiveness of recalls at retail and distribution levels and ensure that affected products are not available for sale, including online sales.
• Conduct sampling and laboratory testing of suspect products and human specimens.
• Strengthen requirements for traceability across the supply chain and food recalls.
• Enhance inspection and oversight of facilities producing or handling ingredients used in infant nutrition.
• Share relevant information through established international information-sharing mechanisms, including INFOSAN.
• Issue targeted alerts to consumers, caregivers, health workers, and retailers, while providing clear guidance on identifying and disposing of affected products.
• Promote breastfeeding and address barriers to accessing safe alternative nutrition.
• Encourage early presentation to health facilities for infants with sudden vomiting.
• Reinforce guidance on dehydration management and red-flag symptoms, while supporting availability of tools for safe clinical management of affected infants.
  

WHO recommends that no restrictions be applied for travel to, or trade with, the countries named in this report, based on the information available on the event reported here.  

European Centre for Disease Prevention and Control (ECDC) and European Food Safety Authority (EFSA). Multi-country foodborne event caused by cereulide in infant formula products. 19 February 2026. Available from: https://www.ecdc.europa.eu/en/publications-data/multi-country-foodborne-event-caused-cereulide-infant-formula-products  

European Food Safety Authority (EFSA). EFSA provides rapid risk assessment on cereulide in infant formula. EFSA; 1 February 2026.  

https://www.efsa.europa.eu/en/news/efsa-provides-rapid-risk-assessment-cereulide-infant-formula  

European Centre for Disease Prevention and Control (ECDC). Communicable disease threats report, 31 January–6 February 2026 (Week 6). ECDC; 12 February 2026.  

https://www.ecdc.europa.eu/sites/default/files/documents/Communicable-disease-threats-report-week-6-2026.pdf  

European Food Safety Authority (EFSA). Precautionary global recall of infant nutrition products following detection of Bacillus cereus. EFSA; 27 January 2026.  

https://www.efsa.europa.eu/en/news/precautionary-global-recall-infant-nutrition-products-following-detection-bacillus-cereus  

European Centre for Disease Prevention and Control (ECDC). Precautionary global recall of infant nutrition products following detection of Bacillus cereus. ECDC; 27 January 2026.  

https://www.ecdc.europa.eu/en/news-events/precautionary-global-recall-infant-nutrition-products-following-detection-bacillus  

European Centre for Disease Prevention and Control. European outbreak case definition: cereulide contamination of infant formula products (EpiPulse event 2025-FWD-00107). Stockholm: ECDC; 2026.

https://www.ecdc.europa.eu/sites/default/files/documents/Case%20definition%20cereulide%20event.pdf

World Health Organization. Strengthening surveillance of and response to foodborne diseases. WHO; 11 December 2025.  

https://www.who.int/publications/i/item/9789240118188  

Austrian Agency for Health and Food Safety (AGES). Update: Information on cereulide in infant formula. AGES; 1 February 2026.  

https://www.ages.at/en/news/detail/update-information-zu-cereulid-in-saeuglingsnahrung  

Call for experts and data on microbiological risk assessment on powdered formulae for infants and young children 

Citable reference: World Health Organization (13 March 2026). Disease Outbreak News;  Recall of internationally distributed infant formula and products containing ARA oil due to contamination with cereulide toxin. Available at: https://www.who.int/emergencies/disease-outbreak-news/item/2026-DON596