The FDA reports at least 31 infant botulism cases linked to ByHeart Whole Nutrition formula, affecting infants hospitalized in 15 states since Aug. 9; the latest case was reported Nov. 13 and no deaths have been recorded. Despite an expanded recall covering all ByHeart infant formulas, the product has reportedly been found on store shelves and sold online, including shipments abroad. At least two families have filed federal lawsuits alleging defective product and negligence. The FDA and state officials are testing leftover and unopened samples, but laboratory detection can be difficult and results are expected in the coming weeks.
ByHeart Baby Formula Tied to 31 Infant Botulism Cases as Recall Expands
The FDA reports at least 31 infant botulism cases linked to ByHeart Whole Nutrition formula, affecting infants hospitalized in 15 states since Aug. 9; the latest case was reported Nov. 13 and no deaths have been recorded. Despite an expanded recall covering all ByHeart infant formulas, the product has reportedly been found on store shelves and sold online, including shipments abroad. At least two families have filed federal lawsuits alleging defective product and negligence. The FDA and state officials are testing leftover and unopened samples, but laboratory detection can be difficult and results are expected in the coming weeks.
02:42 AM, 11/20/2025Health
Federal health officials report that at least 31 cases of infant botulism have been linked to various lots of ByHeart Whole Nutrition infant formula after the company expanded its recall earlier this month. The affected infants were hospitalized across 15 states beginning Aug. 9, with the most recent case reported on Nov. 13; no deaths have been reported.
Infant botulism is caused when a bacterium produces a toxin in a baby’s large intestine. Symptoms can take days to weeks to appear and may include poor feeding, loss of head control, drooping eyelids, a flat facial expression, generalized floppy muscles, and difficulty swallowing or breathing. Prompt medical attention is critical if parents notice these signs.
Although ByHeart expanded the recall to cover all its infant formula products, the U.S. Food and Drug Administration (FDA) says it has received multiple reports that recalled formula is still appearing on store shelves and being offered for sale online and shipped internationally. The agency warns consumers not to use any ByHeart brand infant formulas and to check purchase sources and lot numbers against official recall notices.
At least two families whose infants were recently sickened have filed federal lawsuits alleging the formula consumed was defective and that the company was negligent in selling it. The complaints seek compensation for medical bills, emotional distress, and other damages.
ByHeart said it is "doing everything we can to show up for parents" and pledged to provide timely updates. The company also expressed sympathy for affected families and said it will address legal claims in due course.
The FDA and state health officials have collected leftover formula and are testing unopened product samples as part of the investigation. The agency cautioned that detecting Clostridium botulinum in infant formula is difficult and that a negative test result does not necessarily rule out contamination. Additional test results are expected in the coming weeks.
What parents should do
If you have ByHeart formula, stop using it immediately and follow recall guidance from the FDA or your state health department. If your infant shows any symptoms of botulism, seek medical care right away. Keep packaging and lot information handy for health officials and for possible return or testing.