UPDATE: Federal health officials warn that recalled baby formula linked to a serious botulism outbreak may still be available in stores. As of November 8, 2025, the Food and Drug Administration (FDA) reported 31 cases of suspected or confirmed infant botulism across 15 states following the consumption of ByHeart Whole Nutrition formula.
This alarming outbreak has hospitalized all affected infants, leading to urgent health advisories. The illness, which can result in life-threatening paralysis for babies under a year old, has prompted the FDA to call for immediate action from retailers and parents alike.
The FDA stated, “Epidemiological and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum,” the bacteria responsible for this severe illness. The formula was recalled earlier this month, but reports indicate that it may still be found on shelves in major retailers, including Target, Walmart, Publix, and Whole Foods.
In an urgent plea, the FDA is working with state partners and retailers to ensure an effective recall while investigating the outbreak. ByHeart has acknowledged the situation, stating, “We are investigating every facet of our process” and urging parents to stop using their products immediately.
As of the latest update, the 31 reported cases have emerged from states such as Arizona, California, Illinois, and New Jersey, among others. The outbreak has escalated since the first investigation announcement on November 8, raising concerns as botulism is rarely associated with dairy products, and infant formula has historically not caused such illnesses.
In a notable timeline, ByHeart initially recalled two batches after the California Department of Public Health confirmed positive testing for the bacteria in a sample from an opened can. However, subsequent testing revealed the presence of Clostridium botulinum in unopened products as well, prompting a comprehensive recall of all ByHeart formula.
Health officials are urging parents to remain vigilant for symptoms of botulism, which include constipation, poor feeding, and loss of head control. Symptoms can manifest three to thirty days post-consumption, making early detection crucial. Treatment typically involves an antitoxin administered intravenously.
ByHeart has established a 24/7 support hotline and is offering refunds for purchases made since October. Additionally, the company is facing legal challenges, with parents of affected infants filing lawsuits citing negligence and seeking compensation for medical expenses and emotional distress.
The FDA continues to monitor the situation closely, reinforcing its commitment to public health safety as the investigation unfolds. Parents are advised to wash any surfaces that may have come into contact with the formula and store any remaining product safely for potential testing.
Stay tuned for further updates on this developing situation as authorities work to prevent further illness and ensure the safety of affected families.
