ByHeart Faces Lawsuits Following Recalled Infant Formula Linked to Botulism

The infant formula company ByHeart is facing legal challenges after lawsuits were filed in federal courts alleging that its products caused infant botulism in at least two babies. The lawsuits, lodged by families in Arizona and Kentucky, claim that the ByHeart formula consumed by their children was defective and that the company acted negligently in its sale.

The troubling situation has drawn the attention of the U.S. Food and Drug Administration (FDA), which is currently investigating cases of infant botulism linked to the formula, including two instances in Illinois. According to the FDA, there have been a total of 83 reports of botulism potentially tied to infant formula since August 2023, prompting increased scrutiny on various brands.

In response to the lawsuits, Mia Funt, co-founder and president of ByHeart, emphasized the company’s commitment to infant health. She stated, “Our number one priority is infant health,” and expressed deep sympathy for the families affected by the illness. Funt noted that ByHeart is collaborating with the FDA and independent experts to expedite a recall and investigate the incidents.

The lawsuits seek compensation for medical expenses, emotional distress, and other damages. Both families involved reported that they chose ByHeart’s organic formula, believing it to be a healthier alternative to conventional options. Their disappointment and anger stem from the severe health issues their infants experienced.

On August 22, 2023, the FDA announced that ByHeart had initiated a voluntary recall of two batches of its Whole Nutrition Infant Formula. This recall was later expanded to include all batches of the formula, as the investigation into at least 15 cases of infant botulism continues. Funt reassured consumers, stating, “The safety and well-being of every infant who uses our formula is, and always will be, our highest priority.”

The recall encompasses ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack products distributed nationwide. ByHeart’s formula accounts for less than 1% of all infant formula sold in the United States, and the FDA has indicated that this recall is not expected to impact the overall supply of infant formula or contribute to a shortage.

In addition to addressing the lawsuits, ByHeart is conducting a thorough investigation to ascertain the cause of the contamination. Funt stated that the company is dedicated to providing clear and actionable information to families during this concerning time.

While the FDA has not disclosed the names of other brands potentially implicated in the botulism cases, the agency continues to monitor and investigate the situation closely.

As this situation develops, families affected by the infant botulism outbreak are left grappling with the health implications for their children and the legal complexities that follow. ByHeart’s response underscores the critical importance of safety in infant nutrition and the need for companies to prioritize consumer health above all else.