EFSA to Advise on Cereulide Levels in Infant Formula Following Global Recall
Following a global recall of infant formula products contaminated with cereulide, EU officials are extending recalls of affected products sold in Europe and taking steps to prevent illnesses from cereulide-tainted formula in the future.
Cases of Mild Illness Reported in Europe
Cereluide 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.
The European Centers for Disease Control (ECDC) has received several reports of diarrhea in infants following consumption of recalled products. In one case, an infant who had consumed formula from a recalled batch tested positive for the toxin and developed vomiting and diarrhea. The infant is now recovered.
EU Authorities to Advise on Cereulide Thresholds for Formula Recalls
ECDC, the European Food Safety Authority (EFSA), and the European Commission are coordinating its response to the public health event. EFSA has been requested by the Commission to provide scientific advice on the contamination threshold above which products should be recalled, including the establishment of an acute reference dose (ARfD) for cereulide in infants, and information on typical and higher-end consumption levels of infant formula. The advice will be published in early February 2026.
Global Formula Recall: Nestlé, Danone, Lactalis, Hochdorf
A global recall of infant formula was first issued by Nestlé due to the presence of cereulide in arachidonic acid (ARA) oil used in its products. The company says the presence of cereulide is uncommon, and that it is working with its oil supplier to conduct a root-cause analysis.
Danone later began withdrawing batches of certain infant formula products in targeted markets due to the potential presence of cereulide, to comply with all food safety regulations as “some local food safety authorities are evolving their guidance” in light of the Nestlé recall. Companies Lactalis Nutrition Santé and Hochdorf Swiss Nutrition AG have also recalled batches of formula as a precautionary measure.
Serious Illnesses Under Investigation but Not Confirmed
Although no cases of serious illness have been confirmed in association with recalled Nestlé, Danone, Lactalis, or Hochdorf formula products, the deaths of two infants who consumed recalled Nestlé and Lactalis products are under investigation by French authorities. “To date, no causal link has been scientifically established," the French Health Ministry told Reuters.
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In the UK, a mother asserted that her hospitalized baby had contracted meningitis from the consumption of recalled Nestlé infant formula. Nestlé said it is "categoric that there is no link between the recall and meningitis" and that "cereulide does not cause or transmit meningitis.” The UK Health Security Agency (UKHSA) said there are no confirmed cases of foodborne illness associated with the recalled formula.
Update, February 6, 2026: UKHSA is now investigating 36 cases in which patients exhibited symptoms consistent with cereulide toxin poisoning.
