Lower risk of exposure to cereulide following continued recall of infant formula products across European countries

The multi-country recall of several infant formula products (different batches, products and brands) began in December 2025 following the detection of cereulide, a toxin produced by the bacterium Bacillus cereus. It has been further expanded in 2026 following an EFSA Rapid Risk Assessment, which estimated safety levels of cereulide in infant formula.  

As of 13 February, seven countries have reported investigating the source of gastrointestinal symptoms in infants after the consumption of infant formula products. Investigating and linking cases in this situation is challenging due to limitations in surveillance and the limited possibilities to analyse stool samples for cereulide toxin. In addition, the symptoms of cereulide intoxication, such as nausea, vomiting and diarrhoea, closely resemble common viral gastrointestinal infections, which are widespread in Europe during the winter season. 

Health impact assessed as low to moderate

Most infants have experienced mild gastrointestinal symptoms and have recovered; however, some were hospitalised due to dehydration. 

Infants under six months of age are more vulnerable to dehydration and electrolyte disturbances than older children. Overall, the potential health impact is assessed as low to moderate, depending on the child's age.

Exposure risk decreases following recalls

The recall was initiated after cereulide was detected in batches of infant formula containing arachidonic acid (ARA) oil. Following EFSA’s assessment of estimated safety levels of cereulide in infant formula products, the recall in the EU has been expanded and harmonised. 

The control measures implemented in the European Union have reduced the likelihood of exposure to contaminated products. As a result, the current likelihood of exposure is considered low. However, additional cases may still occur if recalled products remain in households rather than being returned.

Ongoing investigations

Investigations by public health and food safety authorities are ongoing to further identify infants with symptoms of cereulide intoxication and to assess whether recalled batches or additional batches of infant formula products may have been the vehicle. ECDC and EFSA continue to monitor the situation and provide support to EU/EEA countries.

Advice to consumers 

Consumers are advised to follow the guidance issued by their national food safety authorities. Recalled products should not be given to infants or young children and should be returned to the point of sale.

It is important to be vigilant for symptoms of vomiting and diarrhoea in infants and young children, regardless of the underlying cause. The general recommendation is to seek professional medical advice if infants or young children develop persistent or severe gastrointestinal symptoms.  

Notes to the editor

• Cereulide is a toxin that can cause sudden nausea, vomiting, and stomach pain 30 minutes to six hours after ingestion. In younger infants, it can change the body’s salt balance and lead to complications such as dehydration. The possible negative health effects are considered low to moderate and depend on the infant's age, with neonates and infants under six months more at risk of severe disease. 
• In foodborne outbreaks caused by cereulide, cases are usually identified based on an epidemiological link, meaning that people develop symptoms shortly after consuming a food product that later tests positive for the toxin. Laboratory confirmation through stool testing is not routinely performed, as methods to detect cereulide in faecal samples are not widely available in clinical microbiological laboratories. In this event, a limited number of cases have been laboratory-confirmed even though this is not commonly done. In Belgium, cereulide was detected in stool samples from eight symptomatic infants. For most reported cases in other countries, the connection is based on clinical symptoms and reported consumption, and investigations are ongoing.

Because surveillance and the ability to detect linked cases vary between countries, presenting a total case count could be misleading. Instead, the information provided by each country is presented in the ROA.