Safety is arguably the biggest topic in infant nutrition – and recently, the industry has been shaken by multiple major recalls involving powdered formula products.
At the end of 2025, a botulism outbreak in the US was the first time Clostridium botulinum was epidemiologically linked to powdered infant formula. Roughly at the same time, cereulide contamination tied to a low-risk ingredient triggered a major product recall of formula, nutritional products, and oil mixes across nearly 100 countries – impacting manufacturers including Nestlé, Danone and Lactalis.
Both incidents exposed how gaps in monitoring and rare pathogens can spell trouble at scale, with failures at a single supplier or testing blind spot cascading rapidly across markets and product categories.
So what went wrong – and what are some of the underlying fragilities of the current infant food system?
When rare pathogens hit a centralised supply chain
“Several things went wrong in the case of cereulide,” Elena Medo, an expert in human milk science, said. “But one key issue echoes what the FDA has already recognised in pharmaceutical supply chains: the heavy reliance on overseas sourcing. Most active pharmaceutical ingredients come from China and India – and in this case, the ARA supplement used across the infant formula industry was sourced from China.
“The contamination involved Bacillus cereus, which produces cereulide toxin – something I’ve studied for years. I actually testified at an FDA Pediatric Safety Committee hearing back in December 2010, warning that B. cereus and cereulide posed a major risk. At the time, that concern was largely dismissed.”
The problem is that B. cereus is extremely difficult to detect, she said. Cereulide’s heat stability is what makes it similar to botulism – both toxins are difficult to destroy through standard industrial practices.
“It won’t reliably grow under standard testing conditions, but it thrives where you don’t want it. When ‘stressed’ – by heat or environmental changes – it produces spores prolifically, and those spores cannot be destroyed through pasteurisation. If contamination isn’t caught early through proper raw‑material testing, it’s too late.”
Prior to the recalls, there were no regulated safety thresholds for cereulide detection – meaning that detecting it, even at very low levels, resulted in product being discarded.
But ingredient testing is just one facet of a wider problem.
Ingredient testing gaps and regulatory blind spots
“What’s most alarming is the level of supply‑chain centralisation,” Medo said. “When everyone relies on the same inputs, a single failure cascades across the industry. Similar issues showed up later with other manufacturers sourcing from the same suppliers.
“Ultimately, this points to weak incoming‑materials testing and a lack of clear response plans. Raw‑material testing has become far too lax in recent years – and this crisis exposed just how dangerous that fragility is, especially in infant nutrition.”
Medo said that in the US, the FDA deems the heavy reliance on China and India for sourcing APIs [active pharmaceutical ingredients] as a national security and public health risk due to limited oversight. As a result, multiple US administrations have encouraged scaling up domestic ingredient production.
Marketing rules are sorely needed
When it comes to infant product safety, consumer trust is of great importance – but how the infant formula industry recruits consumers has long been a contentious matter.
The World Health Organisation (WHO) has repeatedly warned that brands target parents and expectant mothers through social media, apps and online groups, often with content that isn’t recognisable as pure advertising. WHO has also criticised the sector for using opaque marketing practices to influence feeding decisions before breastfeeding is established and has called on governments to strengthen legislation, monitoring and enforcement.
Medo agreed: it’s high time that marketing regulations – beyond the International Code – are introduced.
“There really aren’t clear guidelines around this,” she said. “There was the Baby Friendly Initiative, but I think it was poorly named, because it made it sound as if hospitals without the certification were somehow unfriendly to babies. I’m not sure that initiative ever really took off – but I do think there absolutely needs to be a return to basics. Rules, protocols and standards cannot replace management and leadership, and there have to be consequences – both at the employee level and the departmental level.”
The enforcement of product recalls also needs tightening – particularly in the US, where the lack of a unified tracking system for sales and distribution has led to recalled products being on sale months after a recall notice had been issued.
“Recalls in the baby food space have been a complete disaster,” Medo said. “Recalled product has still been found on the market as recently as the past few months, even though the ByHeart recall [linked to botulism] dates back to last October.”
“We need to up our game across all foods, because you and I are at risk, our kids are at risk,” she added. “Babies are simply the sharp edge of the sword when it comes to exposing the consequences of sloppy protocols and operations.”
The looming risks in infant nutrition safety
So what could spell the next major crisis in infant nutrition safety?
“I don’t think we’re done with cereulide,” Medo said. “I’ve been looking at cereulide since 2010 – that’s 16 years – and I’ve been worried about it the whole time.”
This is because the toxin is difficult to detect, is heat-stable, and can be fat-soluble, allowing it to persist in lipid‑rich foods or ingredients like ARA oils.
But other environmental risks also deserve tighter oversight.
“There needs to be much closer monitoring of water quality, because powdered infant formula is usually mixed with household water,” said Medo. “If a mother lives in an area with old infrastructure – old lead pipes, for example – there can absolutely be contamination.”
Increased testing of breast milk for pathogens and environmental toxins is much needed, too, she suggested.
“The US is the only developed country that doesn’t routinely test breast milk, even though it appears very quickly and can act as an early indicator of exposure,” she said. “With cow’s milk, you can do more regional testing, and the dairy industry generally does a good job there.
“But once you start bringing in ingredients from multiple sources – especially when there are just one or two central suppliers for a component like ARA that goes into virtually all infant formula – the question shouldn’t just be whether we can add them to infant formula, but whether we truly understand the risks of doing so.”