French authorities are investigating the deaths of two infants who consumed potentially contaminated formula, reigniting concern over a global market dominated by Nestlé SA, Danone SA and Abbott Laboratories.

In the US, health officials are probing hospitalizations linked to formula made by ByHeart Inc., a fast-growing startup that rose to prominence during the 2022 shortage, Accordingt to Bloomberg report. The cases, unfolding on different continents, point to a common fault line, an industry struggling to reconcile innovation with safety.

Formula is often portrayed as a regulatory gold standard. Yet it has repeatedly been disrupted by contamination incidents, factory shutdowns and supply shocks, most notably the Abbott-related shortage that left US shelves bare in 2022.

In response to medical guidance and parental demand, manufacturers have sought to narrow the gap with breast milk by adding lab-engineered fatty acids and other bioactive compounds.

That strategy has lengthened supply chains and shifted risk upstream, to ingredient producers operating under patchier oversight.

“Human milk has thousands of bioactive compounds that interact, not just one or two,” said Rafael Perez-Escamilla, a professor at Yale’s School of

Public Health, warning that isolating and adding select nutrients can carry unintended consequences.

The latest European recall centers on arachidonic acid oil, or ARA, a fatty acid intended to support brain and immune development.

Though long used in formula, demand has surged as standards evolved and new suppliers entered the market, including Wuhan-based Cabio Biotech Wuhan Co., now a significant global source. Regulation, however, remains fragmented across national regimes, often relying on private audits rather than routine public inspection.

Investors have taken note. Nestlé shares are down 7.5 percent this year, while Danone’s stock suffered its steepest drop in more than three decades on Jan. 21 after the company withdrew some formula products in Singapore. Danone is now down 14 percent year-to-date.

The ByHeart episode underscores how even firms born out of past crises are not immune. The company built its brand on cleaner labels and transparency, yet official

THIs later identified spores linked to infant botulism at one of its suppliers. “Industry self-regulation isn’t working very well and is having devastating consequences for a small number of babies,” said Bob Boyle, a pediatric researcher at Imperial College London. Optional additives such as ARA, he argued, largely serve marketing claims, despite recommendations from the European Academy of Paediatrics.

For regulators and manufacturers alike, the message is uncomfortable but clear: sophistication in infant nutrition has outpaced the systems meant to keep it safe