The Department of Public Health and Human Services 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.
The U.S. Centers for Disease Control and Prevention has reported at least 13 cases since August of infant botulism across 10 states in infants who consumed the ByHeart powdered formula.
Cases have so far been identified in Arizona, California, Illinois, Minnesota, New Jersey, Pennsylvania, Rhode Island, Texas and Washington, according to the FDA.
No deaths have been reported at this time.
Officials in several states have collected leftover infant formula for testing, which is underway and results aren’t yet available, but are expected in the coming weeks, according to the FDA.
The product was distributed nationally, including in Montana, but no cases have been identified in the state to date.
ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1 percent of all infant formula sold in the U.S. and “this outbreak does not create shortage concerns of infant formula for parents and caregivers,” according to the FDA.
The U.S. Food and Drug Administration 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 in a release. “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.”
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.
