Preliminary testing indicates that ByHeart Whole Nutrition Infant Formula may contain the bacteria that produce the toxin responsible for infant botulism. At least 13 infants across 10 U.S. states have been hospitalized, prompting a company recall and ongoing investigations by federal and state authorities.
Since mid-August, at least 13 infants aged 2 weeks to 5 months have been hospitalized after consuming ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention (CDC). The affected states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. No deaths have been reported.
The California Department of Public Health warned consumers to stop using the product immediately. ByHeart, based in New York, has voluntarily recalled two lots of its Whole Nutrition Infant Formula, with a best-by date of December 2026, as additional testing continues.
Bold Italics: Bacteria Confirmed in Preliminary Tests
California health officials tested a can of powdered formula consumed by a sick infant. Preliminary results suggest the presence of the bacteria that produce botulism toxin, which has been confirmed in other cases. Further testing is required to validate these findings, as results can take several days.
ByHeart stated, “More testing is needed” to confirm whether the type of bacteria linked to botulism is present. The company emphasized that many bacteria in this family are naturally found in the environment and do not cause illness.
“We take this very seriously,” ByHeart said in a statement, adding that it is cooperating fully with federal authorities.
Bold Italics: Understanding Infant Botulism
Infant botulism is a rare condition that affects fewer than 200 babies in the U.S. each year. It occurs when bacteria produce toxins in the large intestine, leading to symptoms such as poor feeding, drooping eyelids, weak muscle tone, and difficulty breathing. Infants under one year are particularly vulnerable to the spores, which can be found in soil, dust, water, and certain foods like honey.
Dr. Steven Abrams, a nutrition expert at the University of Texas, noted that confirmed outbreaks linked to powdered infant formula are extremely rare. “This would be extremely rare,” he said, underscoring the unusual nature of the current cases.
Bold Italics: Treatment for Affected Infants
The only approved treatment for infant botulism is BabyBIG, an intravenous medication made from the pooled blood plasma of adults immunized against botulism. Developed by California’s Infant Botulism Treatment and Prevention Program, BabyBIG reduces the severity of illness and shortens hospital stays.
Because botulism can impair breathing, affected infants may require ventilators. The CDC reported that all infants in the ByHeart outbreak have received BabyBIG treatment.
Bold Italics: Impact on U.S. Formula Supply
Authorities do not anticipate any nationwide formula shortage resulting from this outbreak. ByHeart accounts for roughly 1% of U.S. formula sales, according to the CDC, and distributes products through its website and retail stores.
This situation contrasts with the 2021–2022 Abbott Nutrition crisis, when contamination issues forced nationwide recalls and triggered prolonged shortages. ByHeart previously recalled five batches in 2022 after a sample tested positive for a different germ, Cronobacter sakazakii, highlighting ongoing regulatory scrutiny.
Bold Italics: Federal Review of Infant Formula
The outbreak has renewed federal attention on infant nutrition safety. Health Secretary Robert F. Kennedy Jr. has directed the FDA to review the ingredients and nutrient content of infant formulas, marking the first major review since 1998. Dubbed “Operation Stork Speed,” the initiative will evaluate public, industry, and scientific input to determine potential improvements and next steps in infant formula regulation.
FDA officials are also investigating 83 cases of infant botulism reported since August, including the incidents linked to ByHeart formula.
Bold Italics: Safety Recommendations for Parents
Parents and caregivers are urged to check for any recalled ByHeart formula in their homes and discontinue use immediately. Healthcare providers recommend contacting a pediatrician if an infant shows signs of poor feeding, unusual weakness, drooping eyelids, or breathing difficulties.
Authorities stress that prompt treatment significantly improves outcomes for affected infants.
Source: AP News – Preliminary tests find germ that causes botulism in ByHeart baby formula
