Since December 2025, there has been a spate of global recalls of several infant formulas following the ongoing detection of the toxin cereulide.

Formula giants Lactalis, Nestlé, Danone, and HOCHDORF have all recalled batches of infant formula in recent weeks, with regulators issuing warnings in dozens of countries, including France, the UAE, Bahrain, and Germany.

Cereulide is a toxin produced by certain strains of the bacterium Bacillus and can lead to nausea, vomiting, and diarrhea in babies.

It is unknown how many babies have been affected by the contaminated formula. However, in France, authorities are reportedly investigating whether the death of two infants is linked to the recalled Guigoz brand of formula milk made by Nestlé.

How Did We Get Here?

Bob Boyle, MB ChB, PhD, clinical reader in pediatric allergy at Imperial College London, London, England, whose research focuses on the need for more robust regulation of the formula industry, said the recalls highlighted a fundamental issue: the inclusion of optional ingredients in formula.

It is believed that the contamination stems from the addition of arachidonic acid oil, supplied by a third party. The oil is added to the formula to allegedly support brain and retina development.

“Optional ingredients are there to support marketing claims. It highlights the imbalance between the needs and well-being of infants and the desire of companies to always maximize profits,” Boyle told Medscape News Europe.

“Optional ingredients don’t do much — they actually do harm,” Boyle said. “There’s no robust science behind the claims. If it helps baby brain development so much, why on Earth are additional ingredients not in all formulas? Most babies across the Western world use formula. It is vital that it is high quality, reliable, and accessible for any baby that needs it.”

Daniel Munblit, MD, PhD, reader in pediatrics at King’s College London, London, England, whose research focuses on advocating for stronger regulation of the infant formula industry, agreed. He said the recalls highlighted the need for stronger regulation.

“If adding in ingredients to formula is essential and necessary for brain development or any other health function, it must be part of every formula. If it’s not essential, all industry should be prohibited from making the claim its essential; otherwise, it’s misleading,” he said.

“It’s very easy for companies to sell ‘premium’ products, but parents pay premium for nothing,” Munblit added. “It’s a very easy sell. Parents don’t have time. They’re not informed. They don’t know where to look for information. Most of what is online is written by the formula industry or with support from the industry.”

On Monday, the European Food Safety Authority (EFSA) announced that it had undertaken a rapid assessment to establish an acute reference dose for cereulide in infants. It also established cereulide concentrations in infant formula that are of potential safety concern.

EFSA’s scientists proposed an acute reference dose of 0.014 μg/kg body weight for cereulide in infants. The recommendation is intended to help decision-makers determine when products should be withdrawn from the market.

Aisling Oslizlok, MSc, pediatric dietician at Genesis Healthcare Center in Dubai, UAE, told Medscape News Europe that the recalls illustrated that the food safety system was working as it should: identifying a potential risk and acting decisively.

“Only specific brands and batches are affected, and to date, there have been no confirmed cases of illness linked to these products in the [Arab Gulf] region,” she said.

“Usually following these events, we tend to see heightened awareness in food safety and testing measures across all manufacturers, so this can hopefully help to reassure worried parents.”

Afif El-Khuffash, MD, consultant neonatologist at the Rotunda Hospital and clinical professor of pediatrics at the Royal College of Surgeons in Ireland, Dublin, Ireland, agreed.

“I’m concerned enough to take it seriously, but not enough to think this represents a fundamental failure of infant formula safety. Recalls like this are unsettling for parents, but they’re also a sign that surveillance systems are active and functioning,” he said.

“In terms of regulation, the focus should be on strengthening what already exists: tighter oversight of global ingredient supply chains, enhanced upstream testing of raw materials, and better international data sharing when issues are identified. Modern formula production is global. Regulation needs to reflect that reality.

Symptoms to Look Out For

El-Khuffash said if symptoms occur, they will typically appear soon after ingestion and include vomiting, diarrhea, lethargy, feeding intolerance, and dehydration in more severe cases.

Oslizlok added that because symptoms are nonspecific and could be caused by numerous common childhood illnesses, it is crucial that a thorough feeding history be undertaken with a healthcare professional to determine if the infant has or may have consumed a recalled batch.

What Do Pediatricians Need to Know?

El-Khuffash said pediatricians need to understand three key points:

• The recall relates to specific batches, not formula feeding as a whole. He does not want the recalls to inadvertently undermine confidence in a safe and necessary feeding option.
• Cereulide is a preformed toxin, not a live infection. That means it has implications for symptom timing and clinical expectations.
• Most exposed infants will be asymptomatic. Management in well babies is reassurance, not investigation.

“The biggest risk here is unnecessary anxiety, formula switching driven by fear, and overmedicalization of otherwise thriving infants,” he said.

Boyle’s advice to pediatricians is simple: Don’t recommend a formula that makes extra claims.

How Can Parents’ Worries Be Quelled?

Oslizlok said pediatricians and other healthcare professionals can play an important role in calming parents and caregivers. She advised:

• Staying calm and factual and avoiding scaremongering language.
• Reassuring families that this is a targeted, precautionary recall.
• Reminding parents not to dilute formula, stockpile unnecessarily, or switch products repeatedly without guidance.
• Calling out any unhelpful rhetoric that dismisses formula feeding or attempts to lay blame on parents.

She also wanted parents and caregivers to be reassured by:

• Checking batch numbers. If their tin of formula does not match the batch numbers affected, it is suitable to give to your child.
• Knowing that safe alternative formulas are available.
• Speaking directly with a pediatrician or dietitian before making changes, or if they are concerned or worried.

Boyle reported receiving funding from the UK Department of Health and Social Care for expert advisory committee work, from the World Health Organization and the Norwegian Directorate of Health for consultancy, and from legal firms for expert witness work related to food anaphylaxis and infant formula health claims.

Munblit, Oslizlok, and El-Khuffash reported having no relevant financial relationships.

Sophie Cousins, MIPH, is a global health journalist who has reported from more than 20 countries.