UPDATE: Federal health officials warn that recalled baby formula linked to a dangerous botulism outbreak may still be available in stores. The Food and Drug Administration (FDA) has confirmed 31 cases of infant botulism across 15 states, with babies falling ill after consuming ByHeart Whole Nutrition formula between August and mid-November.
The alarming outbreak has raised serious health concerns, as all affected infants have been hospitalized, although no fatalities have been reported. The FDA has urged parents to immediately stop using the formula and monitor their babies for symptoms associated with botulism, a potentially life-threatening illness.
“ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country,” the FDA stated in a recent announcement. The company initially recalled two batches of its formula but expanded the recall to include all products last week, which are sold at major retailers like Target, Walmart, and Whole Foods.
Despite the recall, the FDA reports that “recalled formula is still being found on store shelves in multiple states.” This development is particularly concerning as the agency works with retailers to ensure an effective recall while investigating the outbreak.
As of this morning, the 31 reported cases of infant botulism have emerged from states including Arizona, Kentucky, California, and Texas. The outbreak has escalated since the FDA launched its investigation on November 8, when 13 infants were known to have consumed ByHeart products.
The situation developed rapidly. Following an investigation, ByHeart revealed that a sample from an opened can tested positive for the bacteria. Subsequent testing identified the bacteria in unopened formula as well. ByHeart has expressed its commitment to cooperating fully with the FDA and conducting its own investigation to determine the source of the contamination.
Symptoms of botulism can appear within 30 days of consuming contaminated products, with early signs including constipation, poor feeding, and difficulty swallowing. If untreated, the illness can lead to severe paralysis and respiratory distress, requiring extended hospitalization.
In their communications, ByHeart has issued an apology and is providing resources for concerned parents, including a 24/7 support hotline and refund options for recent purchases. The company has emphasized that they are thoroughly reviewing their processes to ensure safety.
Parents are advised to take extra precautions, such as washing any contaminated surfaces and labeling leftover formula with “DO NOT USE.” The Centers for Disease Control and Prevention (CDC) recommends seeking immediate medical care if any concerning symptoms arise, and has established a hotline specifically for this outbreak.
Legal actions have begun against ByHeart as two families of hospitalized infants filed lawsuits citing negligence, demanding compensation for medical expenses and distress. A class-action lawsuit is also pending in New York, alleging deceptive marketing practices.
With the FDA’s investigation ongoing, parents and caregivers are urged to remain vigilant and to share this critical information to protect other families. The situation remains fluid, and further updates are anticipated as health officials continue to assess the impact and scope of this serious outbreak.
Stay tuned for the latest developments on this urgent health crisis.
