ByHeart voluntarily recalls infant formula amid nationwide infant botulism reports
Maile Sipraseuth
IDAHO FALLS, Idaho (KIFI)– Baby nutrition company ByHeart has voluntarily recalled two batches of ByHeart Whole Nutrition Infant Formula.
According to the Food and Drug Administration, on November 7, 2025, the FDA informed ByHeart of approximately 83 reported cases of infant botulism across the United States since August 2025. Among these cases, 13 infants had reportedly consumed ByHeart formula at some point. The FDA has not found any direct connection between infant formula and the reported cases, and there is no historical evidence of infant formula being a cause of infant botulism.
What is infant botulism?
According to Cleveland Clinic, Infant botulism is a rare but serious illness in babies under one year old. It may start with mild signs like constipation or a weak cry but can progress to muscle weakness and breathing problems.
Symptoms include:
Choking when trying to feed
Constipation
Weaker suck or poor feeding
Eyelid drooping (ptosis)
Lack of facial expressions, being unable to lift their head, or other signs of muscle weakness or paralysis
Weaker crying
Weakness or decreased muscle tone, especially starting at the top of their body and limbs, making your baby feel “floppy” and keeping them from reaching or grabbing
Bowel movement changes, like not pooping for days or even weeks at a time
Causes of infant botulism
Infant botulism happens when a baby swallows spores from the bacteria Clostridium botulinum. The spores can survive in harsh conditions and, once inside the baby’s gut, turn into active bacteria that make a harmful toxin. This toxin spreads through the bloodstream and affects the baby’s nerves, causing the symptoms of botulism.
The most common way babies get Clostridium botulinum spores in their gut is from honey.
For more information on the recall, click HERE.