Eight infants have experienced vomiting and gastrointestinal problems after consuming infant formula under investigation for possible contamination with the cereulide toxin. Five of the infants have had to be hospitalized, as reported by the alert bulletin from the European Centre for Disease Prevention and Control (ECDC) and as reported by El País.
In none of the cases could the cause of the vomiting be confirmed through laboratory studies, but the infants had consumed products potentially affected by contamination.
Since December 2025, several batches of infant formula from different brands have been preventively withdrawn from the market following the detection of cereulide presence in some samples.
Cereulide is a toxin that can cause nausea, stomach pain, and vomiting and lead to dehydration in children; its negative effects are generally low to moderate, depending on the age of the child. The most vulnerable to the risks are newborns or babies under six months old. The toxin is produced by the Bacillus cereus bacteria (B. cereus).
New batches of baby formula milk from the Almirón and Bledina brands by Danone have been withdrawn
Warning about the presence of a bacteria in a batch of infant formula from the Almirón brand
Since this bacteria is widely distributed in the environment (soil, water, plants, etc.), it is naturally present in a wide variety of raw materials and food products of both animal and plant origin. According to information from the ECDC, the decision to withdraw the milk from the market was made after detecting contamination in one of the formula ingredients, arachidonic acid, which is used as an omega 6 supplement.
The product withdrawals carried out in recent months have affected several countries, both within and outside the EU. According to European authorities, "the withdrawn products have had wide distribution in the EU and other countries; therefore, the likelihood of exposure to a contaminated formula batch is moderate to high for infants consuming it."
Nevertheless, the ECDC report indicates that the risk for children under one year old, who are initially the most vulnerable to the toxin's effects, is "moderate."
"Many of the contaminated products have been identified and withdrawn, so the chances of exposure are decreasing, which will also reduce the risks," they add.
In its report, the ECDC also mentions the situation in other countries. In Belgium, five babies have tested positive for cereulide exposure in fecal samples; in France, the investigation is ongoing regarding the toxin's relation to 11 infant hospitalizations (consumption of formula milk was confirmed in five of them, while in the rest, its use could not be confirmed), and the UK has reported 36 cases of babies with gastrointestinal symptoms after consuming batches involved in the alert.
As indicated by the Spanish Agency for Food Safety and Nutrition, the European Food Safety Authority (EFSA) has conducted a risk assessment for cereulide in infants and has determined concentrations of cereulide in infant and follow-on formulas that could be concerning from a food safety perspective. This assessment aims to assist EU risk managers in determining when products should be withdrawn from the market as a precautionary measure for public health.
The Aesan has been detailing the withdrawal of batches, affecting products from Nidina 1, Lactalis Nutrition, Babybio Caprea 1, Babybio Optima 1, Almiron, and Bledina.