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

ECDC and EFSA have published a Rapid Outbreak Assessment (ROA) following the ongoing recall of infant formula products due to the detection of cereulide. The assessment concludes that due to the recall, the current likelihood of exposure to contaminated formula is low. Most children who are affected seem to be experiencing mild symptoms. Recalls are still ongoing and investigations continue at national levels.

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 analyze stool samples for cereulide toxin. In addition, the symptoms of cereulide intoxication, such as nausea, vomiting and diarrhea, 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 hospitalized 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 harmonized.

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 diarrhea 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.

More information:
Multi-country foodborne event caused by cereulide in infant formula products, www.ecdc.europa.eu/sites/defau … formula-products.pdf

Provided by European Centre for Disease Prevention and Control (ECDC)