The European Food Safety Authority (EFSA) and the European Centers for Disease Control and Prevention (ECDC) have published an assessment of the ongoing global recall of infant formulas for potential cereulide contamination.

Cereulide is a toxin produced by the bacteria Bacillus cereus that can cause sudden nausea, vomiting, and stomach pain 30 minutes to six hours after ingestion. Nestlé was the first company to issue a recall after it found the toxin in arachidonic acid (ARA) oil used in its formula products. Other brands including Danone, Lactalis Nutrition Santé, and Hochdorf Swiss Nutrition AG issued precautionary recalls soon after. AHA oil originating from a supplier in China is the source of contamination.

After assessing the incident, EFSA and ECDC concluded that exposure to cereulide from infant formula is low. EFSA previously established an acute reference dose (ARfD) for cereulide in infants and determined concentrations of the toxin in infant formula that pose a potential safety concern.

Possible Cases Identified, but Confirmation is a Challenge

As of February 13, 2026, seven countries (Austria, Belgium, Denmark, France, Luxembourg, Spain, and the UK) had reported cases under investigation involving infants with gastrointestinal symptoms who had consumed infant formula products. Although most reported cases involved mild gastrointestinal symptoms, hospitalizations due to dehydration have also been reported.

Experts note that identifying and confirming cases can be challenging because symptoms may resemble common viral gastrointestinal infections, and testing for cereulide in clinical samples is not routine. Investigations are ongoing to identify cases and assess whether recalled products or other batches of infant formula products may have been the vehicle of illness.

Likelihood of Exposure Low, Health Impact Mild to Moderate

As a result of the large-scale recall in the EU, the likelihood of exposure to contaminated products has decreased and is considered low. However, additional cases may still occur if recalled products remain in households rather than being returned.

In terms of health impact, the assessment notes that cereulide intoxication normally presents relatively mild symptoms, but infants under six months may be more vulnerable because they are more sensitive to dehydration and electrolyte disturbances. Overall, the impact of exposure to the toxin is considered low to moderate, depending on the age of the child.