ByHeart® Botulism Lawsuit | ByHeart Recall Lawyer, Attorney

ByHeart recalled all cans of baby formula nationwide after at least 39 babies in 18 states got botulism after being fed the formula.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Infant Botulism cases in all 50 states. If your baby got botulism from ByHeart Baby Formula, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Baby Formula Recall Litigation Group or call toll free 24 hours a day at (866) 920-0753.

UPDATE: ByHeart Baby Formula Linked to 39 Cases of Botulism

As of December 3, 2025, at least 39 babies in 18 states have been diagnosed with infant botulism after they were fed ByHeart Whole Nutrition Infant Formula, according to the CDC Outbreak Investigation.

Botulism can be deadly, but all of the babies survived after they were hospitalized and treated with a botulism antitoxin called BabyBIG.

The illnesses were reported between August 9 and November 13, 2025, but because it can take up to 30 days for botulism to cause symptoms in babies, it is possible that additional states and cases will be reported.

ByHeart Botulism Lawsuits Filed in Kentucky, Arizona

The first lawsuits have been filed in the ByHeart botulism outbreak by parents of babies in Arizona and Kentucky who were hospitalized.

ByHeart Recalls All Formula Nationwide After Botulism Outbreak

On November 11, 2025, ByHeart expanded the recall to include all ByHeart Baby Formula sold nationwide, including every can of ByHeart Whole Nutrition Infant Formula and single-serve “Anywhere Pack” sticks. The recalled products include:

Can UPC: 85004496800
Anywhere Pack (™) UPC: 85004496802</li
Photos of the recalled products

What is the Risk?

Botulism can be deadly and parents should immediately stop using ByHeart formula, according to health officials:

“Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time.”

Where Did Babies Get Sick?

As of December 3, 2025, ByHeart formula has been linked to cases of infant botulism in 18 states, including:

Arizona
California
Idaho
Illinois
Kentucky
Maine
Massachusetts
Michigan
Minnesota
North Carolina
New Jersey
Oregon
Pennsylvania
Rhode Island
Texas
Virginia
Washington
Wisconsin

Botulism Outbreak May Continue to Expand

ByHeart is a popular brand of infant formula. Until the outbreak of botulism, ByHeart sold about 200,000 cans of formula nationwide in major stores like Target, Whole Foods, Walmart, Albertsons, Kroger, Amazon, SamsClub.com, other stores and online.

The true number of illnesses in this outbreak could be higher, and the outbreak may not be limited to the states listed above. This is because infant botulism may not cause symptoms for several weeks (up to about 30 days) in babies.

Another problem is that infant botulism is very rare, so doctors may not properly diagnose a baby who is sick.

ByHeart Formula Tests Positive for Botulism Bacteria

The outbreak was first reported by the California Department of Public Health (CDPH), which tracks cases of infant botulism and provides the antitoxin.

The CDPH tested an open can of ByHeart formula that was collected from the home of a baby who got botulism. The preliminary test results were positive for the bacteria that causes botulism.

Dr. Erica Pan, CDPH Director and State Public Health Officer said:

“We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”

What Causes Infant Botulism?

Infant botulism is a rare but potentially deadly illness that occurs when a baby swallows or breathes in the spores of a bacteria that causes botulism.

This bacteria is called Clostridium botulinum, and it produces one of the most poisonous neurotoxins that is known to humankind.

The botulism bacteria is commonly found in soil and dust, and it is not normally a problem for healthy adults (except in canned foods that have not been properly sterilized), but it is very dangerous for infants.

Babies have an immature digestive system that may not be able to destroy the botulism bacteria. When a baby swallows the spores of Clostridium botulinum, they grow and multiply over the course of several weeks, producing the neurotoxin that causes symptoms.

Signs & Symptoms of Botulism

The botulism neurotoxin causes muscle weakness and paralysis that spreads in the body. Unless it it treated, botulism can paralyze the breathing muscles and cause death. In babies, the symptoms of infant botulism may include:

Breathing that stops or slows
Constipation
Eyelids that sag or partially close
“Floppy” body
Absence of gagging
Loss of head control
Paralysis that spreads downward
Poor feeding and weak suckling
Respiratory failure
Extreme tiredness (lethargy)
Weak cry

What is ByHeart?

ByHeart is a small formula manufacturer, making up only about 1% of the market. It has only been sold in the U.S. since it launched in March 2022, becoming the first new infant formula manufacturer in over 15 years to be registered with the FDA. Unfortunately, safety concerns about contaminated formula began to surface almost immediately.

What To Know About ByHeart’s Safety Record

ByHeart announced its first recall in December 2022, less than a year after it started selling baby formula in the U.S.

No illnesses were reported in the previous recall, but a dangerous bacteria called Cronobacter sakazakii was found in a 3rd-party facility where ByHeart baby formula was canned.

Cronobacter is the same type of bacteria that led to major baby formula recalls for Similac, Alimentum, and EleCare in February 2022, and then Enfamil Nutramigen in December 2023.

ByHeart Had Previous FDA Warning for Contamination

In August 2023, ByHeart received a formal FDA warning letter after inspectors found “significant violations” of good manufacturing practices, including a failure to establish a system of process controls to make sure that their infant formula is not contaminated with microorganisms.

Botulism Food Poisoning Lawsuits

Every case is unique, but a botulism lawsuit will likely seek to recover damages for medical expenses, physical pain and suffering, emotional distress, long-term injuries (such as permanent disability), or death.

Can I File a Lawsuit for Botulism?

Yes. Botulism lawsuits can be filed by people who got sick in outbreaks after eating contaminated food, including baby formula. These cases are food poisoning lawsuits. They typically accuse the manufacturer of negligence for failing to take adequate steps to ensure the safety and sterility of their food product.

How Much Money Is My Lawsuit Worth?

The amount of money you can get from a food poisoning lawsuit varies widely, and not every case will end in a settlement or payout.

However, past outbreaks of food poisoning have resulted in payouts ranging from a few thousand dollars, to millions of dollars. In general, multi-million dollar payouts are more likely for severe cases of food poisoning that caused severe long-term complications or deaths.

Examples of Damages in Botulism Lawsuits

Lawsuits involving infant botulism might seek compensation for:

Wrongful death
Hospitalization
Months of recovery and ongoing check-ups
Disabilities related to muscle paralysis
Brain damage due to respiratory failure
Developmental delays
Nerve damage
Paralysis
Lifelong motor-skills disabilities
Emotional distress and trauma
Rehabilitation and occupational therapy

What Evidence Do I Need?

The potential payout depends on unique factors like who was responsible, long-term health impacts, and the victim’s ability to prove that a contaminated food was the source of their illness.

To pursue a botulism lawsuit, you will need to have a diagnosis, medical records, and evidence of a specific food source. If you believe you qualify to file a botulism lawsuit, talk to a lawyer right away.

Do I Have a ByHeart Botulism Lawsuit?

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ByHeart Botulism Lawsuit