After even more reports of babies who got botulism, ByHeart has expanded a recall to include every single can of ByHeart Whole Nutrition Infant Formula and single-serve Anywhere Pack sticks sold nationwide.
ByHeart sells about 200,000 cans of infant formula every month in stores like Target, Walmart, Albertsons, Whole Foods, and online.
ByHeart said it decided to recall all ByHeart products after a late-night call from the FDA notifying the company of 2 more cases of botulism in babies from North Carolina and Kentucky who were fed the formula.
As of November 10, this outbreak includes 15 infants with botulism from 12 states since August 2025, according to the CDC Investigation.
ByHeart urged parents and caregivers to “immediately discontinue use and dispose of the product.”
Babies may not show symptoms of botulism for up to 30 days after eating contaminated formula.
The symptoms start with constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing, respiratory arrest (breathing stops), and death.
Botulism can be deadly and you should seek immediate medical attention if your child consumed ByHeart formula and is experiencing symptoms of botulism.
Source: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)