A total of 31 infants have been hospitalized due to an outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) reported the increase in cases on November 19. The outbreak now spans 15 states, with eight new cases identified since the last update on November 14.

The affected states include Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The CDC noted that the illnesses began between August 9 and November 13, 2025. All hospitalized infants were fed various lots of the ByHeart formula.

According to the FDA, laboratory confirmation for some cases is still pending. Of the 23 infants for whom age and sex data is available, their ages range from 16 to 200 days, with 11 identified as female. Fortunately, no fatalities have been reported in connection with this outbreak.

The FDA has stated that the bacterium Clostridium botulinum, which causes botulism, can lead to severe illness in infants. Symptoms may include poor feeding, constipation, and difficulty swallowing, which can escalate to respiratory issues. The CDC advises parents to monitor their infants for these symptoms and seek immediate medical care if they arise.

In response to the outbreak, ByHeart initiated a voluntary recall of its Whole Nutrition infant formula on November 8, following notification from the FDA about the ongoing investigation. The recall was expanded on November 11 to include all batches of the formula, both in cans and single-serve sticks, sold nationwide.

ByHeart confirmed that recent testing revealed the presence of Clostridium botulinum in some samples of their formula. The company stated, "After the FDA informed us of the infant botulism outbreak on November 7, we immediately partnered with IEH Laboratories & Consulting Group to test cans of ByHeart formula and conducted a nationwide recall."

The FDA is collaborating with state and local health authorities to trace the source of the contamination. Despite the recall, some ByHeart products may still be available in stores, prompting the FDA to work with retailers to ensure their removal. The agency has reassured the public that the outbreak does not pose a risk of formula shortages, as ByHeart products represent only 1% of the U.S. market.

Parents and caregivers are urged to stop using the recalled formula and to dispose of any remaining product. They should also seek medical attention if their infant exhibits symptoms of botulism. ByHeart has provided a contact number for inquiries regarding the recall. The investigation into the outbreak continues as health officials work to ensure the safety of infant nutrition products.