A nationwide recall of powdered infant formula has drawn attention from families across the country after federal officials announced a likely connection between the product and an outbreak of infant botulism. The recall, issued by ByHeart, follows an investigation by the Food and Drug Administration that identified more than a dozen illnesses potentially tied to the formula.
As of Friday, the 14th, the FDA reported 23 cases of infant botulism across 13 states. No deaths have been reported.
Parents who had been using the formula learned of the recall after the product was removed from store shelves and online retailers on Nov. 8. Many stopped using the formula immediately and began monitoring their children for any symptoms. Pediatricians have advised caregivers to stay alert for signs described in the FDA guidance.
According to an FDA fact sheet, initial symptoms of infant botulism can include constipation, poor feeding, loss of head control, and difficulty swallowing. More serious complications may follow, including difficulty breathing and respiratory arrest. The agency notes that symptoms may take several weeks to appear. The Centers for Disease Control and Prevention states that, if untreated, the illness can progress to paralysis and death.
ByHeart first announced a recall affecting two lots of its organic Whole Nutrition Infant Formula. The company later expanded the recall to include all batches of the product as the investigation continued.
In a public statement, company leadership said that the recall reflects a commitment to protecting infant health and providing families with clear information. ByHeart also stated that it is conducting a comprehensive investigation to understand the situation and address parent concerns.
In addition to the reported illnesses, ByHeart is facing at least two lawsuits filed by families who allege that the formula was defective and caused harm. The suits seek compensation for medical expenses, emotional distress, and other damages.
Court filings describe situations in which infants developed concerning symptoms that led to medical evaluation and, in some cases, hospitalization. In one lawsuit, an infant was transported by air ambulance to a children’s hospital and treated for approximately two weeks. Parents involved in the litigation claim the company should be held responsible for ensuring product safety due to the vulnerable population that depends on infant formula.
Federal authorities continue to investigate the outbreak, and families who used the recalled product are encouraged to review recall information and consult medical professionals if they have concerns.
For more on product recall insurance, see Top 5 Trending Insurance Markets of October 2025, Part 5: Product Recall Insurance.