Montana Health Officials Warn Parents to Stop Using Recalled Infant Formula Linked to Botulism Outbreak

Two lots of ByHeart formula recalled after 13 cases reported across 10 states

Food and Drug Administration

By
Nov 10, 2025

HELENA, MT — Montana health officials are urging parents and caregivers to immediately stop using two specific lots of ByHeart Whole Nutrition Infant Formula linked to a nationwide outbreak of infant botulism.

The Montana Department of Public Health and Human Services issued an urgent recall notice Monday after the Centers for Disease Control and Prevention reported at least 13 cases of infant botulism across 10 states in infants who consumed the powdered formula since August 2025. No cases have been identified in Montana to date, though the product was distributed to retail stores statewide and online merchants.

The U.S. Food and Drug Administration has recalled two lots of the formula. Parents should check the lot number on the bottom of their package:

  • Lot 206VABP/251261P2 (“Use by 01 Dec 2026”)
  • Lot 206VABP/251131P2 (“Use by 01 Dec 2026”)

Anyone with these lot numbers should stop feeding the formula to infants immediately and record the lot number to aid the ongoing investigation.

Symptoms to Watch For

Parents should seek immediate medical attention if their child exhibits symptoms of infant botulism, especially if they consumed the recalled formula.

Warning signs 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,” said Dr. Doug Harrington, DPHHS State Medical Officer.

Harrington also recommended providers ask all parents which formula brand they use, alert them to the ByHeart recall, and ensure the recalled formula is not being used.

Public health officials continue to investigate additional potential cases. The recall is not expected to cause a shortage of infant formula.

Retailers and consumers should regularly check the FDA website for the most up-to-date recall information as the investigation continues.

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