ByHeart Infant Botulism Lawsuit Filed Over Child’s Illness From Contaminated Formula

Lawsuit claims infant showed symptoms of lethargy, weakness, feeding difficulties and drooping eyelids after consuming ByHeart formula.

A new product liability lawsuit alleges that contaminated infant formula sold by ByHeart sickened a baby girl in Illinois, leaving her hospitalized and requiring ongoing medical treatment for infant botulism.

The complaint (PDF) was filed by Arian and Turkane Llapashtica on behalf of their infant daughter, Ari Llapashtica, in the U.S. District Court for the Northern District of Illinois on January 12, naming ByHeart Inc. as the sole defendant.

Infant botulism occurs when Clostridium botulinum spores grow in an infant’s immature digestive system and release a potent neurotoxin. Symptoms can include constipation, muscle weakness, poor feeding, breathing difficulties and paralysis, often requiring prolonged hospitalization and supportive care.

The lawsuit ties Ari’s illness to a broader outbreak of infant botulism that federal health officials have been investigating since late 2025, when the U.S. Centers for Disease Control and Prevention (CDC) identified at least 51 suspected or confirmed cases of infant botulism nationwide, including cases in Illinois. Epidemiological and laboratory data eventually linked the illnesses to ByHeart Whole Nutrition infant formula.

ByHeart subsequently issued a voluntary recall on November 8, 2025, for two specific lots of its Whole Nutrition infant formula. Just days later, the company expanded the recall to include all of its infant formula products, including all can sizes and single-serve packets. The Llapashtica’s lawsuit alleges that all affected infants required hospitalization and treatment with BabyBIG, a botulism immune globulin used to neutralize the toxin.

According to the lawsuit, Ari was born healthy in June 2025 and was introduced to ByHeart formula as a supplement to breast milk. Her parents say they chose the product based on its marketing and labeling, which they believed represented a safe and nutritious option for infants. However, after consuming the formula, Ari allegedly began showing alarming symptoms, including lethargy, weakness, feeding difficulties and drooping eyelids.

The complaint states that Ari’s condition worsened over several days, ultimately requiring emergency treatment and hospitalization. She was later admitted for inpatient care due to hypotonia and other neurological symptoms consistent with infant botulism, a rare but potentially life-threatening condition caused by exposure to Clostridium botulinum spores.

“Plaintiffs fed Ari the infant formula until she developed symptoms whereby her pediatrician advised the plaintiffs to switch to a prior formula not manufactured by ByHeart, Inc.”

— Arian and Turkane Llapashtica et al v. ByHeart Inc.

The lawsuit also outlines a history of regulatory concerns involving ByHeart’s manufacturing facilities. It references prior FDA inspections and warning letters that allegedly identified sanitation failures, inadequate process controls and contamination risks at the company’s Pennsylvania production site, including past findings involving Cronobacter sakazakii, another dangerous infant pathogen.

The Llapashticas suggest that ByHeart failed to properly manufacture, test and safeguard its formula products, allowing contamination to occur. Their lawsuit raises claims of strict products liability, breach of warranty, negligence and negligence per se.

They are seeking compensatory damages for medical expenses, pain and suffering, emotional distress and other losses tied to their child’s illness.

ByHeart Infant Formula Lawsuits

Families whose infants consumed ByHeart formula and later developed symptoms consistent with botulism may have grounds to pursue individual compensation.

Lawyers are reviewing potential ByHeart recall lawsuits involving infants who required hospitalization, botulism antitoxin treatment or who experienced ongoing health complications. Investigations are focusing on situations involving:

• Emergency treatment related to suspected botulism
• Confirmed or suspected infant botulism diagnoses
• Infants requiring intensive care or respiratory support
• Lasting neurological or developmental effects

ByHeart infant botulism cases are typically handled on a contingency-fee basis, meaning families face no upfront legal costs and attorneys are only paid if compensation is recovered through settlement or trial.

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