Urgent Baby Formula Recall Announced by Montana DPHHS

An urgent baby formula recall coming out of the Montana Department of Health and Human Services. The state agency says the formula is apparently tied to a botulism risk.

The urgent recall deals with 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," according to a DPHHS press release.

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.

• Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
• Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")

Consumers are advised to verify the lot number on the bottom of their package and record the lot number to aid the ongoing investigation. Parents and caregivers should immediately stop feeding infants the recalled ByHeart formula.

DPHHS says parents should seek immediate medical attention for their child if the child exhibits symptoms of infant botulism.

Symptoms can include:

• Constipation
• Weakness
• Difficulty feeding
• An altered cry
• Loss of head control

Dr. Doug Harrington, DPHHS State Medical Officer. “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. 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.”

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