The infant formula industry faced two major shocks in late 2025 that exposed fundamental weaknesses in how it sources, tests, and monitors ingredients.
At the end of 2025, a botulism outbreak in the US marked the first time Clostridium botulinum was epidemiologically linked to powdered infant formula. Around the same time, cereulide contamination tied to an ARA supplement triggered recalls across nearly 100 countries, affecting manufacturers including Nestlé, Danone and Lactalis. Both incidents share a common root cause: heavy reliance on centralized overseas suppliers combined with insufficient raw-material testing.
The centralization problem
The cereulide contamination involved Bacillus cereus, which produces cereulide toxin. The contaminated ARA supplement used across the infant formula industry was sourced from China. When a single supplier becomes the ingredient source for virtually all manufacturers in a category, a failure at that point cascades rapidly across the entire market.
Elena Medo, an expert in human milk science and founder and CEO of Leonie Health, noted that the problem mirrors what the FDA has already recognized in pharmaceutical supply chains: the heavy reliance on overseas sourcing. Most active pharmaceutical ingredients come from China and India.
Testing blind spots
Cereulide poses particular detection challenges. B. cereus will not reliably grow under standard testing conditions, but it thrives when stressed by heat or environmental changes, producing spores that cannot be destroyed through pasteurization. The toxin is also heat-stable, meaning it can survive standard industrial practices.
Prior to the recalls, there were no regulated safety thresholds for cereulide detection, meaning that even very low levels resulted in product being discarded. But the deeper issue is that ingredient testing has become too lax in recent years. Raw-material testing represents only one facet of a wider problem: weak incoming-materials testing and a lack of clear response plans when contamination is discovered.
Marketing and enforcement gaps
The industry also faces challenges in how it communicates with consumers. The World Health Organisation has repeatedly warned that brands target parents and expectant mothers through social media, apps and online groups with content that isn't recognizable as pure advertising, and has called on governments to strengthen legislation, monitoring and enforcement.
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 remaining on sale months after a recall notice was issued. Recalled products have 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.
The road ahead
Experts worry about future risks. Cereulide remains difficult to detect and can be fat-soluble, allowing it to persist in lipid-rich foods or ingredients like ARA oils. Water quality also deserves tighter oversight, since powdered infant formula is usually mixed with household water. If a mother lives in an area with old infrastructure such as old lead pipes, contamination is possible.
The broader question, according to industry observers, should not just be whether certain ingredients can be added to infant formula, but whether the industry truly understands the risks of doing so when those ingredients come from just one or two central suppliers.