ByHeart Baby Formula Recall Lawsuit

In November 2025, baby formula manufacturer ByHeart announced a nationwide recall of all its Whole Nutrition Infant Formula products following reports of infant botulism linked to the powdered formula. According to the U.S. Food and Drug Administration (FDA), at least 15 cases across 12 states are under investigation for suspected or confirmed infant botulism with confirmed exposure to ByHeart formula.

A mother giving her baby bottle of formula

Protecting Families Affected by the Nationwide Infant Botulism Outbreak

Heninger Garrison Davis (HGD)’s nationally recognized trial lawyers are leading investigations into the ByHeart infant formula recall and its link to severe cases of infant botulism.

Our firm has successfully represented thousands of families in high-stakes product liability and mass tort cases involving defective pharmaceuticals, contaminated medical devices, and unsafe consumer products. With over $3 billion recovered for clients across all 50 states, our record reflects legal excellence and a history of protecting vulnerable consumers.

HGD’s attorneys are board-certified trial advocates and members of the American Board of Trial Advocates (ABOTA), recognized nationwide for their elevated skill, exceptional integrity, and impressive courtroom results.

We’re here to hold major corporations accountable for negligence. If your child became ill after consuming ByHeart Whole Nutrition Infant Formula or Anywhere Packs, our team is ready to help you pursue justice and secure the resources your family needs to heal.

What Happened?

After the FDA announced it was investigating a possible link between ByHeart’s organic Whole
Nutrition Infant Formula and several cases of infant botulism, the company initially recalled two product lots
Days later, ByHeart expanded the recall to include all batches and package types nationwide (NBC News)
The outbreak has primarily affected infants between 16 days and 5 months old, all of whom were hospitalized, though no deaths have been reported
The Centers for Disease Control and Prevention (CDC) explains that infant botulism occurs when babies ingest food contaminated with Clostridium botulinum, a bacterium that produces a toxin capable of attacking the nervous system

Symptoms of Infant Botulism

Parents and caregivers should watch for symptoms appearing within a few days or even weeks after feeding, including:

Constipation
Poor feeding or a weak cry
Loss of head control
Difficulty swallowing or breathing
Muscle weakness or paralysis

Because botulism can progress rapidly, the FDA urges caregivers to seek immediate medical attention if symptoms develop and to preserve the product packaging for potential testing.

Who May Be Eligible to File a Claim

You may qualify for a ByHeart baby formula lawsuit if:

Your infant consumed ByHeart Whole Nutrition Infant Formula or Anywhere Packs, and
Your child was diagnosed with botulism, hospitalized, or experienced a serious illness related to contaminated formula

Families pursuing mass tort claims may recover compensation for:

Medical expenses and hospitalization
Long-term rehabilitation or developmental care
Pain, suffering, and emotional distress
Potential punitive damages for corporate negligence

What Compensation Might Be Available in a ByHeart Lawsuit?

Families may be eligible to pursue compensation for:

Medical treatment and hospitalization
Rehabilitation or developmental therapy
Pain and suffering
In some cases, punitive damages are awarded if negligence is proven

What to Do Next

If your baby used ByHeart infant formula, stop use immediately and:

Preserve the packaging or receipts for testing if your child shows symptoms
Seek medical care right away for any possible botulism signs
Contact Heninger Garrison Davis for a free, confidential consultation about your legal options

You can reach our Birmingham headquarters at (659) 222-4880 or through our online contact form. Our team is available 24/7 to guide you through the process with compassion and expertise.

Our Promise to Every Client: Integrity, Compassion, and Results

Families nationwide choose Heninger Garrison Davis (HGD) because it is one of the country’s leading plaintiff firms, blending large-firm resources with a client-centered approach that ensures every family receives compassionate, personalized attention.

Our attorneys serve in leadership roles within national mass tort steering committees, shaping litigation strategies that influence courts across the United States. Many have been recognized by Best Lawyers in America®, Super Lawyers®, and Martindale-Hubbell® for excellence in complex civil litigation and ethical advocacy.

Every family we represent receives consistent updates, accessible counsel, and the assurance that their case is managed by a firm respected by both peers and the judiciary.

At HGD, we take on powerful corporations with one guiding principle: protecting people, not profits. We do so on a contingency basis, meaning you owe no fees unless we recover compensation for you. Contact us today for a free, confidential consultation to discuss your legal options.

ByHeart Baby Formula Recall FAQs

What is infant botulism, and how is it different from foodborne botulism?

Infant botulism occurs when Clostridium botulinum spores grow inside a baby’s intestines, releasing toxins that affect the nervous system. Unlike foodborne botulism, which results from consuming pre-formed toxins, this form develops internally due to the presence of immature gut bacteria.

Which ByHeart products are being recalled?

All ByHeart Whole Nutrition Infant Formula products—both in cans and “Anywhere Packs”—are included in the nationwide recall. The FDA advises families to stop using all ByHeart formula and dispose of or save it for testing if symptoms appear.

How can I check if my formula is part of the recall?

All batches of ByHeart formula distributed nationwide are part of the recall. Check the lot number and expiration date on the bottom of your container; if it’s a ByHeart formula purchased after August 2025, discontinue use immediately.

What if my baby seems fine after using ByHeart formula?

Botulism symptoms can take anywhere from days to weeks to appear. Watch for signs of constipation, a weak cry, or poor feeding for at least 30 days. If symptoms develop, seek medical care immediately and retain the product container for testing purposes.

How does a mass tort differ from a class action?

In a mass tort, each family files an individual claim, allowing compensation to match specific injuries. In a class action, plaintiffs share one collective case. HGD’s attorneys assess which approach best protects your rights and maximizes recovery.

How long do I have to file a claim?

Deadlines vary by state but typically range from one to two years after the injury or the date of discovery. Because time limits can affect eligibility, contact an attorney as soon as possible to preserve your rights and evidence.

What evidence should I keep for my case?

Keep unopened or partially used cans of ByHeart formula, purchase receipts, medical records, hospital discharge summaries, and any communications with your healthcare provider. This documentation can help support your claim and strengthen the investigation.

Can I still file a claim if my baby recovered?

Yes. Even if your child has recovered, you may still have a case if they were diagnosed with or treated for botulism. Compensation may cover medical costs, emotional distress, and any long-term monitoring or rehabilitation needs.