Precautionary global recall of infant nutrition products following detection of Bacillus cereus toxin

News

Multi-country recalls of several infant nutrition products (different batches, products, and brands) are ongoing following the detection of cereulide, a toxin produced by the bacterium Bacillus cereus, which can cause nausea, vomiting, and diarrhoea. The precautionary recalls and withdrawals were initiated in December 2025 and continue in January 2026 as a preventive public health measure. The recalls are global, with products sold in both Europe and countries outside of Europe.

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. As the products are being withdrawn and recalled in many countries, the likelihood of further exposure is decreasing.

ECDC has received reports of diarrhoea in infants following consumption of the recalled products. National investigations are ongoing, and ECDC has not been informed of any severe cases related to this event so far. In one case, an infant who had consumed formula from a recalled batch tested positive for the toxin and developed vomiting and diarrhoea, with a favourable recovery.  

It is important to note that vomiting and diarrhoea in infants are common symptoms and can be caused by many different factors, including viral infections such as norovirus.

Public health advice and recommendations

For infants who develop vomiting or diarrhoea after consuming infant formula included in the recall, ECDC recommends seeking medical advice from a healthcare professional, or, if the symptoms are severe (e.g. dehydration or persistent vomiting), at an emergency department. Gastrointestinal symptoms in infants can rapidly lead to complications, regardless of the underlying cause.

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

Public health response and coordination

ECDC is monitoring the event and providing scientific advice and guidance to support national investigations, while facilitating timely information exchange between countries. ECDC, the European Food Safety Authority (EFSA), and the European Commission are working hand in hand to ensure a coordinated and effective response to this multi-country event.

To inform risk management decisions, EFSA has been requested by the European Commission to provide scientific advice on the contamination threshold above which products should be recalled. The request includes two specific questions: Establish an Acute Reference Dose (ARfD) for cereulide in infants, and provide information on typical and higher-end consumption levels of infant formula. 

The advice will be published on EFSA’s website at the beginning of the week starting 2 February 2026.

More information

Information on the food safety actions taken at the EU and national level is shared through the Rapid Alert System for Food and Feed (RASFF), the EU’s platform for exchanging information on risks related to food and feed: RASFF Window - Consumers Portal