ByHeart Faces Lawsuits Over Defective Infant Formula Linked to Botulism

ByHeart is responding to lawsuits filed by families whose infants fell ill from botulism linked to its formula. The lawsuits, initiated in federal courts in Arizona and Kentucky, allege that the ByHeart formula was defective and that the company acted negligently in its sale. The families seek compensation for medical expenses, emotional distress, and other damages, expressing shock and anger over their children’s suffering.

In a statement to NBC 5, Mia Funt, co-founder and president of ByHeart, emphasized, “Our number one priority is infant health.” She extended condolences to the affected families and affirmed the company’s commitment to working with the Food and Drug Administration (FDA) and independent experts to address the situation. The FDA is currently investigating cases of infant botulism, including two confirmed cases in Illinois.

The lawsuits were triggered after reports of at least 15 infants across the United States experiencing symptoms related to Clostridium botulinum, a bacterium known to cause severe illness. Initially, ByHeart had issued a voluntary recall of two batches of its Whole Nutrition Infant Formula. However, as the investigation progressed, the company expanded the recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack products.

Funt stated, “The safety and well-being of every infant who uses our formula is, and always will be, our highest priority.” This nationwide recall aims to protect infants and provide families with clear information regarding the affected products.

The FDA has been closely monitoring the situation since August, receiving 83 reports of botulism potentially linked to infant formula. While ByHeart’s formula represents less than 1% of the total infant formula market in the United States, the FDA has indicated that the recall is not expected to contribute to national supply shortages.

As part of their legal action, parents Stephen and Yurany Dexter from Flagstaff, Arizona, and Michael and Hanna Everett from Richmond, Kentucky, contend that they chose ByHeart’s organic formula as a healthier alternative to traditional options. They are now advocating for accountability and transparency regarding the safety of infant nutrition products.

The FDA continues its investigation, and ByHeart is committed to conducting a thorough examination of the circumstances surrounding the cases of infant botulism. As the situation develops, the company pledges to keep the public informed and cooperate fully with federal authorities.

ByHeart’s response and the ongoing investigations highlight the critical importance of safety in infant nutrition, as families across the nation seek assurance that the products they trust for their children are safe.