11/11/2025
National Outbreak of Infant Botulism Linked to ByHeart Infant Formula
Caregivers advised to dispose of recalled product
BOSTON (November 11, 2025) — The Massachusetts Department of Public Health (DPH) is advising parents, caregivers, and health care providers that ByHeart Inc. is recalling its infant formula because it may be contaminated with the bacteria Clostridium botulinum that can make infants sick. No cases of infant botulism have been identified in Massachusetts.
On November 8, 2025, the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) posted that they were investigating an outbreak of infant botulism linked to ByHeart powdered infant formula. As a result of the investigation, ByHeart Inc. on November 11 voluntarily recalled all lots of powdered Whole Nutrition Infant Formula. ByHeart products are distributed online and nationwide. Caregivers are advised not to use ByHeart formula.
Formula from ByHeart Whole Nutrition Infant Formula should be thrown away immediately or returned to the store where they were purchased. Before disposing of any ByHeart formula, write down or take pictures of the lot numbers, which can be found on the bottom of the cans. Check for any formula you may have removed from the original can and placed in another container. Wash all items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
Infant botulism is a rare and serious illness that is caused when infants inhale or swallow the spores produced by Clostridium botulinum bacteria. Under certain conditions, the spores can grow inside the infant and produce toxins that can make infants very sick. Symptoms can take anywhere from several days to several weeks to appear.
Most infants with infant botulism may develop constipation, poor feeding (sucking and swallowing), loss of head control, and difficulty swallowing. Other symptoms may include decreased facial expression, a weak or altered cry, or other signs of muscle weakness. Infants with botulism must be treated quickly to stop symptoms from progressing to flaccid (floppy) paralysis and breathing difficulties.
Caregivers should seek immediate medical care for their infant if they consumed ByHeart Whole Nutrition Infant Formula and develop any symptoms of infant botulism. Health care providers should immediately report any cases of suspected infant botulism to their local health department or DPH 24/7 at (617) 983-6800.
Infants who consumed the recalled infant formula should be monitored for symptoms for 30 days after their last exposure to the formula. There is no testing or treatment recommended for infants who consumed the recalled formula but who do not have symptoms of infant botulism.
Caregivers should contact their infant’s pediatrician or health care provider if they have any questions about their infant’s health. Individuals with questions about the recall may contact FDA at the link below or the DPH Division of Food Protection at fpp.dph@mass.gov or (617) 983-6712. Updates to the national investigation are expected to be posted on the CDC’s and FDA’s webpages as they become available:
Infant Botulism Outbreak Linked to Infant Formula, November 2025 | CDC
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA
In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula | FDA Includes pictures of the recalled product and how to find lot code information.
According to FDA, ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the United States, and this outbreak does not currently create any concerns of a possible shortage in infant formula.
