Feds Investigate Botulism Cases Linked to ByHeart Infant Formula

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA), alongside the Centers for Disease Control and Prevention (CDC) and state health officials, is investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. As of November 14, 2025, 23 infants across 13 states have been reported as suspected or confirmed cases.

The investigation began after epidemiologic data suggested that ByHeart formula might be contaminated with Clostridium botulinum, the bacteria responsible for infant botulism. Symptoms often start with constipation, poor feeding, and loss of head control, which can escalate to respiratory issues.

As of the latest reports, all infants who fell ill have been hospitalized, and while no fatalities have been noted, the situation remains serious. Health officials urge parents to stop using any remaining ByHeart formula products and seek medical attention if their child shows any symptoms.

The FDA expanded its recall on November 11, 2025, to include all ByHeart Whole Nutrition Infant Formula products, covering both cans and single-serve “anywhere pack” sticks. The recall was prompted by the number of illnesses reported and preliminary lab results that detected the toxin-producing bacteria in an opened can of formula.

Testing and inspections are ongoing to pinpoint the contamination source. Parents who suspect their child may have ingested the affected formula should contact their healthcare provider. The investigation continues as officials work to determine if other batches of formula are implicated in the outbreak.