An infant formula manufacturer has announced a nationwide recall after an outbreak of botulism, traced to tainted batches of its product, hospitalized 15 babies in a dozen states.
The recall of ByHeart Whole Nutrition powdered formula, announced on the company’s website, comes as the Food and Drug Administration investigates as many as 84 serious cases of infant botulism dating back to August. Authorities say the formula was contaminated with Clostridium botulinum, the potentially deadly bacteria that causes botulism.
“We’re writing to you today to tell you that we have decided to voluntarily recall all ByHeart formula nationwide” including cans and portable, single-serving packets, according to a statement on the company’s website. “This decision was made to ensure your baby’s safety.”
ByHeart had centered its recall on two batches of its Whole Nutrition Infant Formula on Nov. 8, but broadened it earlier this week “following notification from the [FDA] of a broader ongoing investigation into a recent outbreak of infant botulism,” according to the statement.
Federal health officials say botulism is a severe illness but that no deaths have been reported so far.
“Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants,” says Sandra Eskin, CEO of Stop Foodborne Illness and former food safety official with the U.S. Department of Agriculture. Babies suffering from botulism, she says, may have a range of symptoms — from constipation and poor appetite to a droopy eyelid, difficulty sucking or swallowing and respiratory distress .
Issues Began In August
The FDA and Centers for Disease Control and Prevention are leading the nationwide investigation but are collaborating with the California Department of Public Health Infant Botulism Treatment and Prevention Program and other state and local health authorities.
The world’s only source of infant botulism treatment, the California program alerted federal authorities in August when it “noted an increase in infant botulism cases linked to ByHeart powdered infant formula,” CDPH announced. Preliminary tests on one sample of the powdered formula identified the bacteria; the state agency then alerted the CDC.
As of Wednesday, 15 infants in confirmed cases had been hospitalized in 12 states. The illnesses have occurred in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
The FDA said in a statement that its investigation found that ByHeart brand formula “is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States.”
The company sells roughly 200,000 cans of infant formula a month online, as well as in stores such as Albertsons, Amazon, Kroger, Walmart, Whole Foods, Target and SamsClub.com.
The recalled Whole Nutrition Infant Formula products are from Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”) and Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”). The company says the affected canned products have the bar code number is 85004496800, and the Anywhere PackTM bar code number is 85004496802.
Investigating the Source
Infant formula can be contaminated with botulism during the manufacturing process, typically through one of the ingredients or a non-sterile manufacturing or packing facility. Eskin says ordering ByHeart formula online is about as safe as buying it in a grocery store, “unless the formula package has been tampered with.”
Although the federal government doesn’t require manufacturers to test for Clostridium botulinum in infant formula, Eskin says ByHeart is now voluntarily testing its products; the company confirmed it on its website.
But it isn’t the first time contaminated formula made babies sick. In 2022, Abbott Nutrition infant formula tainted with Cronobacter bacteria resulted in the death of two infants and triggered a nationwide shortage of baby formula.
“Given this outbreak and the one a few years ago, we are concerned that the testing requirements for infant formula may not be rigorous enough,” Eskin says.
