Since August 2025, a troubling outbreak of infant botulism has swept across the United States, sending shockwaves through families and the baby formula industry alike. At the center of this crisis is ByHeart, an organic baby formula manufacturer, which has now recalled all of its Whole Nutrition infant formula products nationwide after at least 15 infants were hospitalized in a dozen states. The move, announced on November 11, 2025, comes as federal and state health officials scramble to contain the outbreak and reassure parents about the safety of infant nutrition.
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have been at the forefront of the investigation, urging parents and caregivers to immediately stop using any ByHeart Whole Nutrition infant formula, regardless of lot number, can, or single-serving packet. The CDC has also advised families to store any leftover ByHeart powdered formula for potential testing if more cases emerge. If a month passes without symptoms, the leftover formula can be safely discarded.
So far, no deaths have been reported, but the numbers are alarming. From August 1 through November 10, 2025, 84 infants nationwide have been treated for botulism. Of those, 36 had consumed powdered infant formula, and 15 of that group—over 40%—had consumed ByHeart formula, even though the brand represents just about 1% of all infant formula sales in the U.S., according to the FDA. This disproportionate representation has intensified scrutiny. As the FDA put it, "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 affected infants, ranging in age from just 16 days to about five months, fell ill between August 9 and November 10. The illnesses have been reported in states as varied as Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. All 15 infants required hospitalization, underscoring the severity of the illness.
ByHeart’s decision to expand its recall came after a late-night call with the FDA, which had identified two additional cases linked to their formula. Mia Funt and Ron Belldegrun, co-founders of ByHeart, expressed their distress in a public statement: "We are so sorry for the immense anxiety and fear that we have been causing you these past few days. As parents and as founders, that is the absolute last thing we would ever want to do."
Clostridium botulinum, the bacterium responsible for botulism, is a rare but potentially fatal pathogen. The illness disrupts the nervous system, and symptoms in infants can include respiratory difficulty, sluggish pupils, constipation, diminished reflexes, weakened gag reflexes, drowsiness, a weak cry, poor muscle tone, droopy eyelids, and trouble sucking or swallowing. These symptoms may begin up to 30 days after consuming contaminated formula. The CDC stresses that treatment should begin immediately after a clinical diagnosis is suspected, rather than waiting for laboratory confirmation from a stool specimen. If botulism is suspected, doctors can administer an antitoxin that may help treat the infection.
State health departments have echoed federal warnings. In Illinois, where two infants became ill after consuming ByHeart formula—one confirmed with infant botulism Type A, the other pending confirmation—the Department of Public Health (IDPH) issued a strong advisory. Dr. Sameer Vohra, IDPH Director, emphasized, "The health and safety of our youngest Illinoisans is one of our highest priorities. We are urging all parents, guardians, and childcare providers to take immediate action by following the recall guidance and stop using any ByHeart Whole Nutrition Infant formula. If your child has consumed this product and shows any signs of illness, please seek medical care immediately."
The IDPH further advised parents to discard or return all unopened ByHeart formula for a refund and to retain any opened containers if their infant consumed the formula in the past 30 days, in case testing becomes necessary. Childcare facilities were also instructed to remove the recalled formula from their premises. The FDA recommends thoroughly washing any items or surfaces that have come into contact with the formula using hot, soapy water or a dishwasher.
The origins of the contamination are still under investigation. According to the California Department of Public Health, the world’s only source of infant botulism treatment, it was their Infant Botulism Treatment and Prevention Program that first alerted federal authorities in August after noticing an uptick in cases linked to ByHeart formula. Preliminary testing on one sample of the powdered formula identified Clostridium botulinum, prompting the CDC to get involved. Contamination of infant formula can occur during the manufacturing or packing process, often through one of the ingredients or a non-sterile environment.
ByHeart has stated that it is now voluntarily testing its products with third-party laboratories, even though federal regulations do not currently require manufacturers to test for Clostridium botulinum in infant formula. The company’s products are widely available, sold both online and in major retail stores such as Target, Walmart, Whole Foods, Albertsons, Amazon, Kroger, and SamsClub.com. The recalled products include Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2, both with use-by dates of December 1, 2026, and bar codes 85004496800 and 85004496802, respectively.
This is not the first time the U.S. has faced a major baby formula recall. In 2022, Abbott Laboratories recalled three popular baby formula products and closed a major factory after Cronobacter bacteria was detected, leading to two infant deaths and a nationwide shortage. That crisis left parents scrambling, with 40% of popular formula brands sold out at retailers and stores like Walgreens and CVS imposing purchase limits. In December 2023, Nutramigen Hypoallergenic Infant Formula Powder was also recalled after batches exported from the U.S. to Israel tested positive for Cronobacter, marking the second recall from Reckitt/Mead Johnson Nutrition in less than a year.
The FDA has assured the public that the current ByHeart recall does not pose a risk of widespread formula shortages, noting that ByHeart accounts for less than 1% of the U.S. market. Still, the outbreak has reignited concerns about the rigor of safety testing in the infant formula industry. Sandra Eskin, CEO of Stop Foodborne Illness and a former food safety official with the U.S. Department of Agriculture, remarked, "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."
As the investigation continues, parents and caregivers are left grappling with anxiety and uncertainty. The federal government, which is the largest buyer of baby formula in the country, is working with state agencies to monitor the situation and provide guidance. For now, the message from health officials is clear: if your child has consumed ByHeart Whole Nutrition infant formula and shows any signs of illness, seek medical care immediately, and follow all recall instructions to ensure the safety of the youngest and most vulnerable Americans.
The unfolding ByHeart recall is a stark reminder of the challenges in safeguarding the nation’s food supply, especially for those who depend on it most. As families wait for answers, vigilance and swift action remain the best defense.
