More than 50 infants across 19 states have been hospitalized in a widening botulism outbreak linked to contaminated baby formula, federal health officials confirmed on Wednesday. The outbreak has prompted a nationwide recall of ByHeart powdered infant formula products.
As of December 10, 2025, a total of 51 babies with confirmed or suspected infant botulism have been identified after consuming the formula. All affected infants required hospitalization, though fortunately no deaths have been reported.
Timeline of the Outbreak
The initial cluster of cases began between August 9 and November 19, 2025, affecting babies ranging from just 2 weeks to 5 months old. But the problem appears to have deeper roots. Health officials recently expanded their case definition, identifying 10 additional cases that occurred from December 2023 through July 2025, suggesting the contamination issue may have been present for longer than initially thought.
“Previously, case counts included illnesses from August 1, 2025, onward. With an expanded definition, CDC and state partners identified 10 additional cases that occurred from December 2023 through July 2025,” the agency stated.
What Products Are Affected?
The recall specifically targets two lots of ByHeart Whole Nutrition Infant Formula: Lot 206VABP/251261P2 and Lot 206VABP/251131P2, both with a use-by date of December 1, 2026. Parents and caregivers are being urged to take immediate action.
“ByHeart officials say parents and caregivers who have the formula in their homes should stop using it immediately and dispose of the product,” health authorities warned.
The smoking gun? California officials confirmed that a sample from an open can given to a sick infant contained the bacterium that produces the deadly botulinum toxin. The confirmation came after a standard mouse sickness test yielded alarming results.
“These mice got sick really quickly,” Pan said in an interview.
Company Response
ByHeart has recalled all lots of its infant formula in coordination with the FDA, though the company notes no previously unopened product has tested positive for the bacteria. The company, which holds approximately 1% of the U.S. infant formula market, emphasized its rapid response to the crisis.
“From the very beginning, we have acted quickly and decisively to remove any potential risk—immediately voluntarily recalling the relevant batches of our formula that the FDA told us were consumed by infants in their investigation,” the company stated. ByHeart is offering replacement formula at no cost to affected customers.
Understanding Infant Botulism
Infant botulism is a rare but serious condition that affects fewer than 200 babies annually in the United States. It occurs when Clostridium botulinum bacteria colonize an infant’s intestines and produce a toxin that can cause paralysis and, in severe cases, death.
Why are babies particularly vulnerable? Their immature gut microbiomes don’t yet have the beneficial bacteria that would normally prevent harmful organisms from taking hold.
All children affected in the ByHeart outbreak have received BabyBIG, an intravenous medication derived from immunized adult blood plasma. It’s the only treatment available worldwide for infant botulism, developed by California’s Infant Botulism Treatment and Prevention Program. The price tag? A staggering $69,300 per vial.
No Shortage Expected
Should parents worry about a repeat of the 2022 formula shortage crisis? Probably not. Since ByHeart sells approximately 200,000 cans per month and represents less than 1% of the U.S. infant formula market, experts don’t anticipate supply disruptions.
In response to the outbreak, the FDA and Department of Health and Human Services announced “Operation Stork Speed,” a comprehensive plan to increase testing of baby formulas for various contaminants including arsenic, lead, and mercury.
For parents of the 51 hospitalized infants, however, the assurances come too late. As federal investigators continue tracing the contamination source, the incident serves as a stark reminder of how vulnerable our youngest consumers remain to food safety breakdowns in even the most regulated products.
