Even more babies have been diagnosed with infant botulism after they were fed ByHeart Whole Nutrition Infant Formula, according to an update from the FDA.
As of November 14, 2025, a total of 23 babies who consumed ByHeart Whole Nutrition Infant Formula have been hospitalized with infant botulism in 13 states.
The states were cases were reported include Arizona, California, Illinois, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
The first lawsuits have also been filed by the parents of babies who were hospitalized with botulism in Arizona and Kentucky.
ByHeart recalled every single can of infant formula due to the outbreak. Before the recall, the company sold about 200,000 cans of formula per month.
It can take up to 30 days for botulism to cause symptoms in babies such as constipation, “floppy” body, poor feeding or weak sucking, extreme tiredness, loss of head control, and more.
Botulism can be deadly, so parents should be vigilant. The FDA is urging parents to watch infants for symptoms and hold onto their cans of ByHeart formula, just in case they need to be tested:
- If your child consumed ByHeart formula and is experiencing symptoms (see below) seek immediate medical attention.
- If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.
- If you still have the formula in your home, you should:
- Take a photo or record the information on the bottom of the package.
- Keep the container in a safe spot and be sure to label that product as DO NOT USE.
- If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
Source: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
