Several EU member states are investigating reports of babies developing vomiting and diarrhoea after consuming certain infant formula products that have been recalled since December 2025 because they may contain cereulide, a toxin produced by the bacterium Bacillus cereus.
Seven countries had reported investigations into the source of gastrointestinal symptoms in infants by 13 February, the European Centre for Disease Prevention and Control (ECDC) said in a statement on Thursday.
Cereulide intoxication can be difficult to identify and link to a specific product because surveillance differs between countries and stool testing for the toxin is not widely available, it added.
The symptoms — including nausea, vomiting and diarrhoea — can also resemble common winter viral stomach infections.
Some infants were hospitalised due to dehydration, although most had mild symptoms and recovered, according to the same statement.
Infants under six months are more vulnerable to dehydration and changes in the body’s salt balance than older children, it said, adding that the overall potential health impact was assessed as low to moderate depending on age.
Recall expanded after EU risk assessment
The recall began after cereulide was detected in batches of infant formula containing arachidonic acid (ARA) oil, the ECDC statement said.
The recall in the EU was later expanded and harmonised following a Rapid Risk Assessment by the European Food Safety Authority (EFSA), which estimated safety levels of cereulide in infant formula.
Control measures in the European Union have reduced the likelihood of exposure to contaminated products and the current likelihood of exposure is considered low.
Additional cases could still occur if recalled products remain in households rather than being returned.
Public health and food safety authorities are continuing investigations to identify more infants with symptoms consistent with cereulide intoxication and to determine whether recalled batches — or additional batches — were involved.
Consumers were advised to follow guidance from national food safety authorities, avoid giving recalled products to infants or young children, and return them to the point of sale.
