Concerns Rise Following Botulism Outbreak Linked to ByHeart Baby Formula

Mon Nov 10 2025 01:16:24 GMT+0200 (Eastern European Standard Time)

Health officials have issued a warning after preliminary tests found botulism-producing bacteria in ByHeart baby formula, leading to recalls and investigations as 13 infants across the U.S. fell ill.

At least 13 infants in 10 states have been affected by a botulism outbreak linked to ByHeart Whole Nutrition Infant Formula. Health officials have advised consumers to stop using the product amid ongoing testing and a recall of two lots. The outbreak has raised alarm given its rarity in relation to powdered formulas, while federal authorities undertake a review of safety standards in the baby formula industry.

Preliminary tests showed that ByHeart baby formula contained the type of bacteria that produces the toxin linked to an infant botulism outbreak, California health officials said.

The outbreak has sickened at least 13 infants in 10 states. No deaths have been reported.

“Consumers in possession of this product should stop using it immediately,” the California Department of Public Health said in a statement late Saturday.

More tests of ByHeart Whole Nutrition Infant Formula are pending as state and federal health officials investigate the outbreak that began in mid-August. The New York-based company this weekend recalled two lots of the powdered product.

Infant Botulism Outbreak

The outbreak of infant botulism has affected infants aged 2 weeks to 5 months since mid-August. All were hospitalized after consuming ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention.

The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

ByHeart officials have agreed to recall two lots of the company’s Whole Nutrition Infant Formula, as per the U.S. Food and Drug Administration. The formula has a best-by date of December 2026.

California health officials tested a can of formula that was fed to a baby who fell ill. The results “suggest the presence” of the bacteria that produces the botulism toxin.

ByHeart officials stated that “more testing is needed” to definitively identify the type of bacteria involved, mentioning that it comes from a large family of bacteria found naturally in the environment.

The FDA is investigating reports of 83 cases of infant botulism since August, including those associated with ByHeart baby formula.

Understanding Infant Botulism

Infant botulism typically affects fewer than 200 babies in the U.S. each year and is caused by bacteria that produce toxins in the intestines. Infants under the age of 1 are particularly vulnerable.

Symptoms such as poor feeding, loss of head control, drooping eyelids, and difficulty breathing may not appear until weeks after exposure.

Treatment and Response

The only recommended treatment is BabyBIG, an IV medication developed by California’s Infant Botulism Treatment and Prevention Program. This treatment has been administered to all affected infants in the current outbreak.

Impact on Formula Supplies

There is currently no risk of formula shortages because of the ByHeart recall; the company represents about 1% of the national formula market.

Ongoing Safety Reviews

Federal health officials have launched a comprehensive review of the U.S. food supply, particularly focusing on the safety and ingredients of infant formulas following recent health concerns.