WASHINGTON — A second lawsuit has been filed against baby formula company ByHeart by a Washington-based food safety law firm following an outbreak of infant botulism cases across the country.
Earlier this month, ByHeart was notified by the Federal Drug Administration (FDA) about potentially dozens of cases of infant botulism that were reported nationwide since August 2025.
“Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants, which occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest," according to the FDA.
A recall for ByHeart Whole Nutrition Infant Formula was issued earlier this month, and as of mid-November, 24 infants have been sickened nationwide.
Two of those cases were reported in Washington: one in Pierce County and one in Lewis County.
No deaths have been reported.
Since the announcement of the cases, Bainbridge Island-based food safety firm Marler Clark has been contacted by over a dozen families across the United States.
Marler Clark filed the first suit against ByHeart last week on behalf of two families impacted. The first suit was brought on by a family in Arizona and Kentucky. This second suit covers a family in California.
In a statement, the California family at the center of this recent suit said:
“We believed we were making a well-informed choice by feeding [the baby] ByHeart, but instead, we feel like we have inadvertently participated in the poisoning of our baby. No family should ever have to endure this kind of pain, and no baby should suffer severe medical consequences from ingesting contaminated formula. We hope sharing [the baby]’s story will ensure accountability and protect other families from experiencing what we went through.”
Marler Clark is calling on the company to pay for medical bills and lost wages for parents.
In a statement regarding the suit, ByHeart said:
“Our number one priority is infant health. We express our deepest sympathy to the families currently impacted by the cases of infant botulism. We are working with the FDA and independent experts to implement the recall quickly while the factual investigation continues. We are committed to getting answers—including partnering with the FDA and independent experts—and will share updates as soon as we can.”
The company also said that for the time being, they are focused on the recall and the investigation rather than litigation.
“Our number one priority is infant health. We express our deepest sympathy to the families currently impacted by the cases of infant botulism. We are working with the FDA and independent experts to implement the recall quickly while the factual investigation continues. We are committed to getting answers—including partnering with the FDA and independent experts—and will share updates as soon as we can," said ByHeart Co-Founder and President Mia Funt.