Bengaluru: The U.S. FDA on Monday urged the infant-formula industry and supply-chain partners to exercise substantive oversight of their suppliers following multiple product recalls and recent botulism cases – the first outbreaks in the country linked to baby formula in nearly 50 years.
The Food and Drug Administration has so far investigated two multi-state outbreaks of infant botulism associated with two separate brands of powdered infant formula – ByHeart and Nara Organics – that resulted in the products being recalled, it said in its letter to manufacturers, packagers, distributors, exporters, importers, and retailers of infant formula.
The FDA said it expects manufacturers to understand where their ingredients come from, how they are produced, what risks they may carry and whether those risks are effectively controlled. The 2025 ByHeart outbreak was the first confirmed U.S. botulism outbreak linked to infant formula in nearly 50 years, according to the agency.
A global contamination event from late 2025 through early 2026 also resulted in nearly 150 suspected and confirmed cases of cereulide intoxication across 10 countries, which was traced to contaminated arachidonic acid oil used as an ingredient in infant formula.
In May, New Zealand’s a2 Milk recalled three batches of its a2 Platinum formula sold in the U.S. after detecting the toxin cereulide. These public-health events taken together “reflect a pattern that warrants attention from both FDA and the infant formula industry,” the health regulator said.
The FDA also recommended that infant formula manufacturers and their supply-chain partners be on top of important safety signals such as applicable recall notifications, outbreak investigations and import alerts. The agency is continuing to investigate the root causes of the 2025 and 2026 infant botulism outbreaks.
