Updated Nov. 25, 2025 — ByHeart, the maker of a powdered infant formula connected to a recent botulism outbreak, said its products may be broadly contaminated after lab tests found Clostridium botulinum Type A in multiple samples.
In an update posted Nov. 24, the company reported that five of 36 samples tested positive for the bacteria. ByHeart said it cannot rule out the possibility that all of its formula across product lots may have been contaminated.
Federal investigators have linked at least 31 reported cases of infant botulism in 15 states to shipments of ByHeart’s Whole Nutrition infant formula as of Nov. 19. No deaths have been reported.
Infant botulism symptoms, which can take weeks to appear, include poor feeding, weakened head control, drooping eyelids, a flat facial expression, and difficulty swallowing or breathing, according to public health guidance. Medical experts note that Clostridium botulinum can be unevenly distributed in powdered formula, so not every baby who consumes a contaminated batch will become ill.
Although the company and regulators issued a nationwide recall earlier in the month, the FDA reported on Nov. 20 that ByHeart formula had still been found for sale at some major retailers.
ByHeart said it will issue full refunds for products bought through its website on or after Aug. 1. The company is conducting a comprehensive audit of its production chain — reviewing suppliers, raw ingredients, packaging and transportation — and is expanding product testing as it works to identify the root cause.
Several parents of affected infants have filed lawsuits alleging the product was defective and that ByHeart was negligent in selling it. Those suits seek compensation for medical expenses, emotional distress and other damages.
Reporting contributed by CBS News and The Associated Press.