Updated on: November 25, 2025 / 2:13 PM EST / CBS News
ByHeart, a maker of baby formula linked to a botulism outbreak that has sickened dozens of infants across the U.S., said all its formula may have been contaminated. In a Nov. 24 update posted on the company’s website, ByHeart said five of 36 samples tested positive for Clostridium botulinum Type A, the bacteria that can cause the potentially deadly illness.
“Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company said in a statement.
As of Nov. 19, at least 31 reported cases of infant botulism in 15 states have been tied to various shipments of the ByHeart Whole Nutrition infant formula, according to the FDA. No deaths have been reported.
Symptoms of infant botulism, which can take weeks to develop, include poor feeding, loss of head control, drooping eyelids and a flat facial expression, according to the CDC. Babies may also have problems swallowing or breathing.
Clostridium botulinum can be unevenly distributed throughout powdered formula, so not all babies who consume a tainted product will fall ill, medical experts say.
Despite a nationwide recall earlier this month, the FDA said on Nov. 20 that it had received reports that ByHeart formula was still available at major retailers.
In its Nov. 24 update, ByHeart said it will provide full refunds for all products purchased through its website on or after Aug. 1. The company said it is focused on finding the root cause through a rigorous audit of every step of its product development chain — from suppliers and raw ingredients through packaging and transportation — and is testing more product samples.
Some parents of sickened babies have filed lawsuits against ByHeart. Two lawsuits filed earlier this month allege the product was defective and that the company was negligent in selling it; the parents are seeking compensation for medical bills, emotional distress and other harm.
—With reporting by CBS News’ Kiki Intarasuwan
Edited by Alain Sherter. The Associated Press contributed to this report.
