Preliminary Tests Suggest Botulism-Linked Bacteria in ByHeart Powdered Infant Formula; 13 Infants Hospitalized

Preliminary tests suggest botulism-linked bacteria in ByHeart powdered infant formula

California health officials said preliminary laboratory testing indicated a can of ByHeart Whole Nutrition powdered infant formula contained the type of bacteria that can produce the toxin tied to a recent outbreak of infant botulism. Confirmatory testing is pending as state and federal investigators continue their work.

The outbreak has hospitalized at least 13 infants across 10 states; no deaths have been reported. The U.S. Centers for Disease Control and Prevention (CDC) says the affected babies ranged in age from about two weeks to five months. Cases have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

Recall and ongoing investigation

ByHeart voluntarily recalled two lots of its Whole Nutrition Infant Formula over the weekend; the recalled product carries a best-by date of December 2026. California officials tested a can of formula that had been fed to an infant who fell ill; initial results "suggest the presence" of the type of bacterium that can produce the botulism toxin identified in other cases, though confirmatory testing can take several days.

The U.S. Food and Drug Administration said it is investigating a broader set of reports: the agency has received reports of 83 cases of infant botulism since August, which include the cluster linked to ByHeart products.

What causes infant botulism

Infant botulism is rare in the United States, typically affecting fewer than 200 infants a year. It occurs when certain bacteria — usually introduced as hardy environmental spores — grow in an infant's large intestine and produce a toxin that interferes with nerve function. Spores have been found in soil, dust and water; infants can also be exposed by ingesting honey, which is why honey is not recommended for children under 1 year.

Symptoms may take days to weeks to appear and include poor feeding, weak muscle tone ("floppiness"), loss of head control, drooping eyelids, a flat facial expression, and trouble swallowing or breathing. Because breathing can be affected, infants with botulism often require hospitalization and sometimes mechanical ventilation.

Treatment

The specific treatment for infant botulism is an antitoxin called BabyBIG, an intravenous product made from pooled adult plasma from donors immunized against botulism. California's Infant Botulism Treatment and Prevention Program developed BabyBIG and remains the sole supplier. The antitoxin can shorten hospital stays and reduce the severity of illness; the CDC said all children in the ByHeart-linked cluster have received BabyBIG.

Impact on formula supply and context

Authorities say the current incident is unlikely to cause a national formula shortage. ByHeart represents an estimated ~1% of U.S. formula sales and sells both online and in retail outlets. The episode evokes the 2021–22 crisis involving a different bacterium, cronobacter sakazakii, and products manufactured by Abbott Nutrition, which led to plant closures and a prolonged shortage. ByHeart previously recalled batches in 2022 after a positive cronobacter test at a packaging plant, and the FDA issued a warning letter to the company in 2023.

Federal review of infant formula

Federal health officials have announced a renewed review of infant formula ingredients and manufacturing practices, described by agencies as the most comprehensive examination of formula nutrients and components since the late 1990s. The Food and Drug Administration is soliciting input from industry, health experts and the public as it determines next steps.

Guidance for parents and caregivers

If you have ByHeart Whole Nutrition powdered formula: stop using it immediately if it matches the recalled lots and best-by date; follow recall instructions and return or dispose of affected product per official guidance. Watch infants closely for symptoms listed above and seek immediate medical attention if you notice feeding difficulties, weakness, difficulty breathing, or reduced responsiveness. Contact your pediatrician or local health department with questions.

Officials emphasize that the laboratory findings are preliminary. Investigators are continuing testing to confirm whether the specific botulism-causing bacterium is present in the product and to determine the outbreak's source.

Source: Associated Press reporting, U.S. CDC and FDA statements.