ByHeart Botulism Lawsuit Overview

ByHeart infant formula recall lawsuits are being filed by families of infants who consumed contaminated formula and were later hospitalized for severe botulism symptoms.

The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration first alerted the public about the botulism outbreak in November 2025, after receiving multiple reports of infants developing constipation, weak muscle tone, feeding difficulties and respiratory distress. Investigations revealed that many of the children who became ill had consumed ByHeart powdered infant formula shortly before the onset of symptoms.

After identifying ByHeart powdered formula as the likely source of contamination, the FDA announced a ByHeart formula recall covering specific production lots tied to early illness reports. Subsequent testing confirmed the presence of Clostridium botulinum in samples collected from consumer homes, prompting the company to expand the recall to all unexpired powdered formula products.

Families are now filing ByHeart botulism lawsuits alleging that the manufacturer failed to prevent contamination and distributed a product that posed a serious risk to newborns. The claims seek compensation for emergency medical treatment, prolonged hospitalization, long term neurological or developmental complications and the emotional and financial toll placed on families whose infants became seriously ill.

Who Can File a ByHeart Botulism Lawsuit?

ByHeart lawsuits are being filed by parents whose children were hospitalized or required medical intervention after exposure to contaminated formula. You may qualify for a ByHeart botulism lawsuit if your child:

• Consumed recalled ByHeart Whole Nutrition powdered infant formula
• Developed symptoms such as constipation, weak muscle tone, poor feeding or respiratory distress
• Was diagnosed with suspected or confirmed infant botulism
• Required emergency treatment, hospitalization or botulism antitoxin
• Experienced long term health complications following the illness
• Suffered harm that you believe is connected to contaminated powdered formula

To determine whether your family may be eligible for a ByHeart botulism lawsuit, submit your information for a free case evaluation. An attorney can review your claim, identify the product and lot number involved and explain your legal rights.

ByHeart botulism injury claims are handled on a contingency fee basis, meaning there are no upfront costs and no legal fees unless compensation is recovered.

2025 ByHeart Lawsuit Updates

• December 3, 2025 Update: Health officials expanded their investigation into the ByHeart infant formula outbreak after additional cases were identified in multiple states. The rising number of hospitalizations has increased scrutiny of the company’s manufacturing processes and the circumstances that led to the contamination.
• November 11, 2025 Update: ByHeart announced a nationwide recall of all unexpired powdered infant formula after state laboratories confirmed botulinum contamination in several consumer samples. Families affected by the outbreak began filing lawsuits almost immediately, alleging the company failed to keep its products safe.
• November 6, 2025 Update: Federal health officials began actively tracking a multi-state ByHeart infant botulism outbreak after the Food and Drug Administration (FDA) was alerted on November 6, 2025 that California officials had identified a cluster of cases linked to the formula.

ByHeart Infant Formula Recall

The U.S. Food and Drug Administration announced a recall for ByHeart Whole Nutrition Infant Formula on November 8, 2025, after the California Department of Public Health identified the presence of botulinum toxin in an open can of ByHeart infant formula that was fed to an infant with infant botulism.

At that point in the investigation, authorities had documented approximately 83 infant botulism cases nationwide since August 2025, including 13 illnesses involving infants who consumed ByHeart formula. The FDA reported illnesses had been recorded in the following states:

• Arizona
• California
• Illinois
• Minnesota
• New Jersey
• Washington
• Oregon
• Pennsylvania
• Rhode Island
• Texas

Around the same time, ByHeart reported that a third-party laboratory had tested 36 unopened cans from retained inventory, with five cans testing positive for C. botulinum contamination. These findings confirmed that the contamination originated before products reached consumer households.

Which ByHeart Formula Was Recalled?

On November 11, 2025, ByHeart broadened the recall to cover all lines of powdered infant formula products sold in the United States, including both the standard canisters and the single-serve Anywhere Pack pouches.

What Should You Do If You Used Recalled ByHeart Formula?

Parents and caregivers who purchased ByHeart Whole Nutrition powdered infant formula should take immediate steps to protect their child’s health and preserve important evidence. Anyone who still has recalled formula in their home should stop using the product right away and check the batch code and use-by date on the bottom of the container to confirm whether it is included in the recall.

If your infant has developed any symptoms consistent with botulism, including constipation, weak muscle tone, poor feeding or difficulty breathing, contact your child’s healthcare provider as soon as possible. Preserve the formula packaging, receipts or any remaining product in accordance with the CDC guidance, as these may be needed for laboratory testing or future legal claims.

ByHeart advised customers to take the following steps if an infant becomes ill after consuming the recalled formula:

• Call an FDA Consumer Complaint Coordinatorif you wish to speak directly to a person about your problem. 
• Complete anelectronic Voluntary MedWatch form online. 
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA. 

What is Infant Botulism?

Infant botulism is a rare but serious illness caused by Clostridium botulinum, a bacterium that produces a neurotoxin capable of disrupting normal nerve and muscle function. Unlike foodborne botulism in adults, which typically results from eating preformed toxin, infant botulism occurs when babies ingest bacterial spores that colonize the intestines and begin producing toxin inside the body.

Since infants have immature gut flora and underdeveloped immune systems, they are far more vulnerable to this form of exposure.

The botulinum toxin interferes with the communication between nerves and muscles, blocking the release of acetylcholine, a chemical necessary for muscle contraction. As toxin levels increase, infants can experience a gradual loss of muscle tone, feeding ability and respiratory strength.

Without timely treatment, botulism can progress from mild symptoms such as constipation or lethargy to more severe complications including paralysis and breathing difficulties.

Symptoms and Injuries Linked to ByHeart Formula

Infant botulism affects the nervous system and can lead to a variety of neurological and muscular symptoms. During the ByHeart outbreak, many infants showed early signs of illness that gradually worsened without prompt treatment.

Common symptoms reported in affected infants included:

• Constipation or difficulty passing stool
• Poor feeding or weak suck
• Weak muscle tone and reduced head control
• Drooping eyelids or changes in facial expression
• Unusually weak or quiet cry
• Lethargy or decreased responsiveness
• Difficulty swallowing
• Progressive muscle weakness
• Respiratory problems requiring medical support

These symptoms often develop slowly but can escalate quickly as the toxin interferes with muscle and nerve function. Severe cases required hospitalization, antitoxin treatment and close monitoring in pediatric intensive care units.

Typical Treatment for Infant Botulism

Treatment focuses on managing symptoms, supporting breathing and neutralizing the botulinum toxin. Infants diagnosed with suspected or confirmed botulism may require:

• Administration of BabyBIG (botulism immune globulin) to help neutralize circulating toxin
• Hospitalization for monitoring and supportive care
• Intravenous fluids for hydration and nutrition
• Respiratory support, including oxygen or mechanical ventilation when necessary
• Feeding assistance through specialized techniques or feeding tubes
• Physical or occupational therapy during recovery to rebuild muscle strength
• Long term follow up to monitor neurological or developmental impacts

Infants who receive prompt treatment typically recover, but the illness can require prolonged hospitalization and ongoing medical care.

Allegations Raised in ByHeart Botulism Lawsuits

Recent lawsuits raise a series of product liability and consumer safety concerns, including:

• Failure to maintain sanitary manufacturing conditions
• Failure to prevent contamination with Clostridium botulinum
• Failure to promptly warn parents once early illnesses were reported
• Misrepresentation of formula safety and purity
• Negligent manufacturing and quality control
• Distribution of formula that posed life threatening risks to newborns

These allegations form the basis of claims seeking compensation for medical expenses, lost income, future care needs and emotional harm.

ByHeart Recall Lawsuit Examples

ByHeart Infant Botulism Lawsuit

On November 12, 2025, Michael and Hanna Everett filed a ByHeart botulism lawsuit on behalf of their four-month-old daughter, Piper, after she was diagnosed with infant botulism following consumption of ByHeart powdered infant formula.

The complaint, filed in the U.S. District Court for the Eastern District of Kentucky (Case No. 25-cv-00422), alleges the baby required emergency hospitalization and intensive care after developing severe neurological symptoms attributable to the recalled product.

According to the lawsuit, the Everetts purchased the formula believing it was a high-quality, “clinically proven” alternative, only to discover it had been recalled due to contamination. Their complaint claims ByHeart failed to ensure the formula was free of dangerous bacteria, neglected proper safety protocols and omitted adequate warnings, despite known risks linked to the outbreak.

Infant Hospitalized After Consuming ByHeart Formula

Scott and Chelsea Dexter filed a ByHeart infant botulism lawsuit after their four-month-old daughter became severely ill and required emergency air-ambulance transport to a pediatric intensive care unit. The complaint indicates the child developed symptoms of botulism shortly after consuming ByHeart powdered infant formula, resulting in prolonged hospitalization and significant medical intervention.

The lawsuit alleges that ByHeart distributed contaminated formula, failed to implement adequate safety and testing procedures and did not warn parents about the risk of infant botulism associated with its products. The Dexters claim their daughter suffered serious, preventable injuries and will require ongoing monitoring and follow-up care as a result of the exposure.

ByHeart Class Action Lawsuit

A ByHeart class action complaint filed in the Eastern District of New York on November 13, 2025 alleges that ByHeart misled consumers by failing to disclose that its powdered infant formula was contaminated with Clostridium botulinum, the bacteria that causes infant botulism.

The plaintiff, who purchased ByHeart Anywhere Packs and Whole Nutrition cans in the months before the recall, is asking the court to represent all purchasers nationwide, arguing that the recall refund program is inadequate and that families deserve statutory, compensatory and punitive damages.

How to Start a ByHeart Botulism Lawsuit

Families whose infants consumed ByHeart powdered formula and later developed symptoms consistent with botulism may qualify for financial compensation.

Attorneys are reviewing claims involving infants who were hospitalized, required antitoxin treatment or experienced long term health complications linked to contaminated formula. Lawyers are currently investigating:

• Cases involving emergency medical treatment
• Infants diagnosed with suspected or confirmed infant botulism
• Children who required intensive care or ventilatory support
• Long term neurological or developmental concerns following illness

ByHeart botulism claims are handled on a contingency fee basis, meaning there are no upfront costs and no legal fees unless compensation is obtained through settlement or trial.