Investigation into Infant Botulism Cases Linked to ByHeart Baby Formula

Mon Nov 10 2025 01:05:56 GMT+0200 (Eastern European Standard Time)

Health officials caution against ByHeart infant formula after multiple botulism cases were reported, urging parents to check their supplies.

A botulism outbreak linked to ByHeart baby formula has affected at least 13 infants across 10 states, prompting a recall of two product lots. Although no deaths have been reported, health officials emphasize the risks associated with the formula, especially for babies under one year old. Testing continues to determine the presence of the bacteria in samples, as stakeholders assess the situation to prevent future occurrences.

California health officials have announced that preliminary tests revealed that ByHeart baby formula contained bacteria associated with a recent outbreak of infant botulism, affecting at least 13 infants across ten states. Although no fatalities have been reported, the California Department of Public Health has recommended that parents immediately cease feeding the affected formula to their children.

The investigation into the botulism outbreak began in mid-August, with samples of the ByHeart Whole Nutrition Infant Formula showing concerning results. Health officials are currently conducting further tests and examinations to ascertain the toxin's presence in the formula. In reaction to the news, ByHeart has issued a recall of two lots of the powdered product, with a best-by date of December 2026.

Understanding Infant Botulism

Infant botulism, primarily affecting babies under one year old, occurs when the bacteria grows and releases toxins in the large intestine. Symptoms may include poor feeding, weakened muscle tone, and difficulty in swallowing or breathing. Early detection and treatment are critical, as the only remedy currently available, known as BabyBIG, requires hospitalization.

Implications for Baby Formula Supply

While there is no immediate danger of a national formula shortage due to this incident, awareness of the composition of infant formulas is increasingly crucial. Officials are reviewing the ingredients and safety standards of all infant formulas in view of recent trends and health reports within the industry.

The Path Forward

Regulatory authorities are taking the outbreak seriously and beginning an investigation into their ingredients, part of a broader initiative to reform the U.S. food supply, including infant products. Stakeholders are urged to stay informed and remain vigilant as testing and investigations unfold.