Botulism Outbreak Investigaion On Infant Formula

A nationwide recall of all formulas from ByHeart’s Whole Nutrition Infant Formula line was announced Tuesday amid an ongoing investigation into a multistate outbreak of Infant botulism linked to the brand.

According to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), at least 15 infants in 12 states have been hospitalized after consuming ByHeart formula between August and early November. The infants ranged in age from approximately 16 to 157 days old, and while no deaths have been reported, all affected children required hospitalization.

The FDA says that of an estimated 84 cases of infant botulism under investigation since August, 36 reported exposure to powdered infant formula — and a disproportionate number of those involved ByHeart products, despite the brand accounting for less than 1% of the U.S. infant-formula market.

The potential contamination appears tied to the bacterium Clostridium botulinum, which produces toxins in the immature gut of infants when spores germinate. Symptoms may include constipation, poor feeding, loss of head control, difficulty swallowing, weak cry or facial expression, and can progress to respiratory failure if untreated. A preliminary lab test from the California Department of Public Health found the toxin-producing bacteria in an opened can of ByHeart formula fed to an infant case.

In response, ByHeart has voluntarily recalled all its formula products nationwide, even though no unopened cans have yet tested positive for contamination. The company said the recall is being done “out of an abundance of caution” and in close collaboration with the FDA.

What parents and caregivers should do:

• Immediately stop using any ByHeart Whole Nutrition Infant Formula product (cans or single-serve packs).
• Record the lot number and ‘use by’ date if available, and store the container aside in a safe spot, labeled “DO NOT USE.”
• Monitor infants who consumed the product — even if no symptoms are present — for several weeks, since symptoms of infant botulism can take time to appear. Immediately seek medical attention if any signs like difficulty swallowing or feeding, limpness, or breathing trouble occur.
• Clean any bottle-preparation equipment or surfaces that may have come into contact with the formula using hot soapy water or a dishwasher.

The investigation remains active, and no other formula brands have been identified as part of this outbreak. Health officials stress that infant formula shortages are not anticipated from this recall, since ByHeart’s market share is small.

Parents still using or with leftover product are urged to check the lot numbers, dispose of any recalled items, and consult their pediatrician promptly if concerned.