A nationwide botulism outbreak among infants has led to the recall of one brand of infant formula.
Through Saturday, there were 13 cases of infants with botulism reported across 10 states, according to the federal Centers for Disease Control and Prevention.
Cases have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington since October.
No deaths were reported, but the 13 babies, ranging in age from 16 days old to 167 days old, were hospitalized.
Infant botulism outbreak: 13 infants sick in 10 states; no deaths. ByHeart infant formula recalled. Seek medical care right away for poor feeding, loss of head control, difficult swallowing, decreased facial expression. Symptoms can take as long as several weeks to develop. pic.twitter.com/7IlDvWaJad
— Deputy Secretary Jim O’Neill (@HHS_Jim) November 8, 2025
Researchers found that the common denominator among the cases was that the babies had been fed ByHeart Whole Nutrition infant formula.
On Sunday, ByHeart recalled two batches of its Whole Nutrition Infant Formula, according to the Food and Drug Administration.
The recall comes as the FDA is investigating 83 cases of infant botulism that have taken place since August.
“The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism,” the statement on the recall said.
The recall notice said “there is no historical precedent of infant formula causing infant botulism. Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust.”
“While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.” Mia Funt, Co-Founder and President of ByHeart said.
The two batches recalled have Batch Codes of 251261P2 or 251131P2. Both have a “use by” date of Dec. 1, 2026.
The information is found on the bottom of a can of the product.
“Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately discontinue use and dispose of the product,” the recall notice said.
“If you’ve discarded any formula from the following batches, ByHeart will replace those cans at no cost,” the recall notice also said.
The FDA said the ByHeart products recalled could have been bought online or at major retailers.
“Infants with botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, but these symptoms can progress to difficulty breathing and respiratory arrest, the FDA said,” according to a report from The Hill.
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