11/11/2025
URGENT RECALL Infant Formula Linked to Botulism Risk
Two lots of ByHeart Whole Nutrition Infant Formula linked to outbreak
The Department of Public Health and Human Services (DPHHS) is advising consumers and health care providers of an urgent recall of two specific lots of ByHeart Whole Nutrition Infant Formula due to an outbreak of infant botulism linked to the product.
Since August 2025, the Centers for Disease Control and Prevention (CDC) has reported at least 13 cases of infant botulism across 10 states in infants who consumed the ByHeart powdered formula. Public health officials continue to investigate additional potential cases. While the product was distributed nationally, including to retail stores in Montana and online merchants, no cases have been identified in Montana to date.
The U.S. Food and Drug Administration (FDA) has issued a recall for the following two lots. Consumers are advised to verify the lot number on the bottom of their package and record the lot number to aid the ongoing investigation:
Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")
Parents and caregivers should immediately stop feeding infants the recalled ByHeart formula.
Parents should seek immediate medical attention for their child if the child exhibits symptoms of infant botulism, especially if they consumed this formula.
Symptoms can include:
Constipation
Weakness
Difficulty feeding
An altered cry
Loss of head control
"The DPHHS urges health care providers to maintain a heightened suspicion for infant botulism in any infant presenting with compatible symptoms who was fed ByHeart powdered infant formula," Dr. Doug Harrington, DPHHS State Medical Officer said. "We also recommend that providers make it a practice to ask all parents or guardians which formula brand is being fed to their infant patients, alert them to the ByHeart recall, and ensure that the recalled formula is not being used."
This recall is not expected to cause a shortage of infant formula.
Retailers and consumers are advised to regularly check the FDA website for the most up-to-date recall information as the investigation into the outbreak continues. The full details of the recall are available on the FDA website: https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
