Formula manufacturer ByHeart has announced a massive recall of its products from stores after at least 15 infants were hospitalized in some 12 U.S. territories for an infant botulism outbreak linked to powdered formula manufactured by the company, which has expanded its massive recall.
The Centers for Disease Control and Prevention (CDC) on Tuesday reported two new cases in Kentucky and North Carolina, joining those also detected in Arizona, California, Illinois, Minnessota, New Jersey, Oregon, Rhode Island, Texas Pennsylvania and the District of Columbia.
ByHeart Infant Formula Recall
ByHeart, a manufacturer of organic baby formula, recalled all of its products sold nationwide on Tuesday, days after some batches were recalled in an expanding outbreak of infant botulism. https://t.co/udNkTlknjB pic.twitter.com/7aptwXJW8p
– CBS Evening News (@CBSEveningNews) November 12, 2025
CDC has reported no deaths to date in connection with this outbreak.
Sick infants range in age from 16 days to five months.
About half are girls, according to a U.S. Food and Drug Administration (FDA) statement released Tuesday.
“In cases with available information on disease onset, symptoms began between August 9 and November 10, 2025.
“All 15 infants were hospitalized,” said the FDA, which noted that all of those affected consumed ByHeart Whole Nutrition powdered formula.
The company already announced the voluntary recall of two batches of the product last Saturday, after receiving a notification from the FDA about an ongoing investigation related to the infant botulism outbreak.
Two days later, ByHeart announced that, with FDA cooperation, it would expand the action to remove all lots of formula cans and individual packages from shelves across the country, “despite the fact that no unopened ByHeart products have tested positive for Clostridium botulinum spores or toxin.”
The appearance of Clostridium botulinum bacteria in food can produce the botulinum toxin responsible for botulism, considered a rare but serious disease.
With information from EFE
