UPDATE: Federal health officials have issued an urgent warning that recalled baby formula linked to a serious botulism outbreak may still be on store shelves. The Food and Drug Administration (FDA) confirmed that 31 cases of suspected or confirmed infant botulism have been reported across 15 states as of November 8, 2025, with infants hospitalized but no fatalities reported.
The contaminated product, ByHeart Whole Nutrition formula, is believed to be tainted with Clostridium botulinum, a bacteria that can cause life-threatening paralysis in infants under one year old. The FDA is urging parents to cease using this formula immediately and to monitor their babies for symptoms, which can include constipation, poor feeding, and difficulty swallowing.
The recall was initiated after the FDA identified an alarming trend of botulism cases linked to ByHeart. The company initially recalled two batches but later expanded this to all of its products, which are sold at major retailers including Target, Walmart, and Whole Foods. Despite this, the FDA reports that recalled formula continues to be discovered in stores across multiple states.
According to the FDA’s Wednesday update, the states affected include Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The outbreak has grown significantly since the FDA began its investigation, which was announced on November 8. At that time, only 13 infants had been confirmed to have consumed the ByHeart formula.
ByHeart, which launched in 2022 and represents about 1% of the U.S. infant formula market, stated in an apology to parents that it is fully cooperating with the FDA’s investigation. The company has established a 24/7 support hotline and is offering refunds for products purchased since October.
What to Watch For: Parents are advised to closely monitor their infants for any symptoms of botulism and to ensure that any remaining formula is clearly labeled as “DO NOT USE.” The Centers for Disease Control and Prevention (CDC) emphasizes the need for vigilance, as symptoms can develop anywhere from 3 to 30 days after ingestion.
Treatment for infant botulism involves administering an antitoxin known as BabyBIG, which requires hospitalization. Parents are urged to seek immediate medical attention if they notice concerning symptoms in their children.
As ByHeart works to address the situation, several families have initiated legal actions against the company, alleging negligence due to the serious health implications faced by their infants. The ongoing investigation by the FDA is expected to yield further developments, and ByHeart is under pressure to implement stronger safety measures.
This is a developing story, and updates will be provided as more information becomes available. Parents and caregivers are encouraged to stay informed and take necessary precautions to protect their infants during this concerning outbreak.
