At least 23 infants across the United States have now been diagnosed with suspected or confirmed cases of botulism linked to ByHeart Whole Nutrition powdered infant formula. The outbreak, which began with 15 cases earlier this month, has escalated rapidly, prompting a nationwide recall and renewed scrutiny of the federal government's ability to respond to foodborne illness.
Escalation of Cases
The California Department of Public Health's Infant Botulism Treatment and Prevention Program (IBTPP) first identified the connection after noticing a surge in requests for BabyBIG, the only FDA-approved treatment for infant botulism. By 14 November, 23 infants from 13 states had been hospitalised and treated, all ranging in age from 16 to 200 days. While no deaths have been reported, the sudden rise in cases underscores how quickly safety signals can intensify.
IBTPP data show that between 1 August and 10 November, 84 infants nationwide received treatment for botulism. Of those, 36 were exposed to infant formula, and 15 had consumed ByHeart products. Despite ByHeart representing only about 1% of US formula sales, the disproportionate number of cases linked to its formula raised alarms at the FDA.
Recall and Federal Investigation
ByHeart initially recalled two lots of formula on 8 November, expanding the recall to all formula nationwide just three days later at the FDA's request. The FDA, CDC, IBTPP, and state partners are now investigating the origin of contamination. FDA spokesperson Emily Hilliard confirmed that the agency is in contact with the company and that the investigation is ongoing.
Botulism occurs when spores of Clostridium botulinum colonise the intestine and release toxins that interfere with nerve signals, leading to muscle weakness and breathing difficulties. Without treatment, the illness can be life-threatening.
Concerns Over Federal Oversight
Experts warn that recent federal actions may have weakened the nation's ability to respond to outbreaks like this one. Susan Mayne, former director of the FDA's Center for Food Safety and Applied Nutrition, noted that the Foodborne Diseases Active Surveillance Network reduced the number of pathogens states must monitor from eight to two earlier this year—botulism was not among them.
Additionally, the National Advisory Committee on Microbiological Criteria for Foods was disbanded before it could release a report on contamination risks in infant formula. Layoffs at both the FDA and CDC have further strained resources, with the CDC's Washington office closure eliminating a key communication channel to Congress.
Sarah Sorscher of the Center for Science in the Public Interest emphasised that such cuts hinder transparency: 'For this outbreak, they would have sent out an alert and scheduled a briefing so members of Congress can know what's going on. In their absence, there's no communication that can come directly from the teams investigating the outbreak.'
Nov. 14 update on infant botulism outbreak: 23 infants sick in 13 states. Do not use ByHeart infant formula. Seek immediate medical care if infant shows: Poor feeding, loss of head control, difficulty swallowing, or decreased facial expressions. https://t.co/DspNrV4HZm pic.twitter.com/1rlGiaqiVD
— CDC (@CDCgov) November 14, 2025
Lessons from Past Shortages
The 2022 formula shortage, triggered by contamination and a factory shutdown, remains fresh in public memory. Experts stress that ByHeart's small market share makes another shortage unlikely, but the outbreak highlights vulnerabilities in the system. Mayne argues that the administration must prioritise protecting against microbial contamination in infant formula, warning that weakened oversight leaves infants at risk.
The Bigger Picture
The ByHeart outbreak illustrates how quickly food safety signals can escalate and how fragile the nation's surveillance systems have become. With 23 infants already affected, the incident is not only a public health emergency but also a test of whether federal agencies can adapt to protect the most vulnerable.
