ByHeart Baby Formula Lawsuits Surge After FDA Confirms Infant Botulism Outbreak

More Than 50 Babies Sickened in 19 States as FDA Expands Recall to All ByHeart Infant Formula Products Made Since 2022

More than 50 infants across 19 U.S. states have been sickened by a growing outbreak of infant botulism tied to ByHeart baby formula products. The U.S. Food and Drug Administration (FDA) has expanded its investigation and warning to include all formula manufactured by ByHeart since March 2022, based on evidence that bacterial contamination may have affected the entire production run. While no deaths have been reported, the cases involve severe and sometimes life-threatening symptoms, and many families have already taken legal action against the manufacturer.

This expanding health crisis has left many parents asking critical questions about the safety of the formula, the timeline of contamination, and what legal rights they may have. For families who trusted this product to nourish their infants, the consequences have been devastating.

Understanding Infant Botulism and Its Link to Formula Contamination

Infant botulism is a rare but potentially fatal condition caused by Clostridium botulinum, a bacterium that produces a dangerous neurotoxin. While the illness affects fewer than 200 babies annually in the United States, it can lead to paralysis, respiratory failure, and long hospital stays.

Babies under one year old are especially vulnerable because their intestinal systems are not yet fully developed. If they ingest spores from contaminated products, the bacteria can germinate in their gut and release the botulinum toxin. This toxin interferes with nerve signals, causing a cascade of symptoms such as:

• Constipation
• Poor feeding
• Weak cry
• Muscle weakness
• Drooping eyelids
• Loss of head control
• Difficulty breathing

Treatment typically involves BabyBIG, an intravenous immune globulin made from adults immunized against botulism. The medication is extremely rare and is only available through California’s Infant Botulism Treatment and Prevention Program.

What the FDA and CDC Have Confirmed About the ByHeart Botulism Cases

On December 10, 2025, the FDA confirmed that at least 51 infants have been diagnosed with botulism after consuming ByHeart formula. The U.S. Centers for Disease Control and Prevention (CDC) also updated its case definition to include any infant exposed to ByHeart formula since its release in March 2022.

According to the FDA and CDC:

• The contamination appears to have persisted across all production runs, lots, and even raw material batches.
• The most recent illness was reported on December 1, 2025.
• At least 12 additional cases were identified under the expanded case definition.
• The CDC could not isolate the contamination to a specific location, time period, or raw ingredient.

This outbreak is not isolated to a single facility or batch. Instead, it appears systemic, raising serious concerns about the company’s long-term manufacturing practices and safety protocols.

Timeline of ByHeart Contamination and FDA Investigations

The issues with ByHeart’s formula span multiple years and facilities. Here’s a breakdown of key events:

• March 2022: ByHeart begins producing formula.
• 2022: Five batches of formula were recalled after cronobacter sakazakii contamination at a packaging plant.
• 2023: FDA issues a warning letter after uncovering unresolved safety concerns, including mold and water leaks.
• Late 2023: A plant in Reading, Pennsylvania, is shut down following FDA inspection.
• July 2025: Ten new botulism cases reported.
• November 2025: ByHeart voluntarily recalls all products, and the outbreak is formally announced.
• December 2025: FDA and CDC expand the scope of the outbreak to include all ByHeart formula ever produced.

The scale and duration of these contamination issues highlight serious gaps in oversight and safety controls within the company’s operations.

How Parents and Caregivers Have Been Affected

For parents whose infants were hospitalized after using ByHeart formula, the expanded warning was both validating and heartbreaking. One parent’s 5-week-old daughter, developed infant botulism in December 2023, shortly after consuming ByHeart. Despite trying to choose the safest product available, she found herself in a medical emergency no parent should face.

Similarly, another child fell ill in March 2025. After months of uncertainty, the inclusion of her child’s case in the FDA’s expanded investigation brought emotional relief, but also renewed anger over the company’s failure to protect its consumers.

These families, and others like them, are now pursuing legal action. Their cases may help expose internal failures at ByHeart and seek financial relief for:

• Hospitalization and treatment costs
• Long-term care and developmental delays
• Emotional distress and pain
• Punitive damages for negligence

Legal Issues and Potential Lawsuits Against ByHeart

The contamination of a product intended for infants raises serious legal questions, especially when it causes serious harm. Lawsuits against ByHeart are already being filed and may fall under the following categories:

Product Liability

Manufacturers are legally responsible for ensuring the safety of their products. If a product is contaminated or defective, and that defect causes injury, the company can be held liable.

In this case, families are alleging that ByHeart formula was defective and that the company failed to warn about or prevent contamination risks.

Negligence

Negligence claims center around the idea that ByHeart failed to follow reasonable standards of care in their manufacturing process. The FDA has documented issues like mold, water leaks, insects, and unsanitary conditions in the facilities.

Failure to Warn

Even if ByHeart was aware of possible risks tied to their product, the company did not issue widespread warnings to consumers until after dozens of babies were already sick. That delay may support claims of failure to warn.

Breach of Warranty

By selling its product as safe, organic, and gentle for infants, ByHeart created an implied warranty. If the product was unsafe or misrepresented, families may argue that the company violated this consumer protection law.

Symptoms to Watch for After Using ByHeart Formula

Botulism symptoms may take days or even weeks to appear after exposure. Parents should be aware of signs such as:

• Lack of bowel movements (constipation)
• Trouble feeding or sucking
• Weak cry or voice
• Loss of muscle tone (limpness)
• Facial drooping
• Breathing difficulties
• Floppy limbs or head

Early detection is crucial. Any child who consumed ByHeart formula and now displays these symptoms should receive immediate medical evaluation. Blood and stool testing can help confirm botulism, and BabyBIG therapy should be administered without delay.

What to Do If Your Child Was Affected by ByHeart Formula

If your child developed botulism or showed symptoms consistent with the illness after consuming ByHeart formula, here are key steps to take:

1. Seek immediate medical treatment. Early intervention can prevent complications. Ask your physician if your child qualifies for BabyBIG therapy.
2. Preserve all packaging. Save any leftover formula, containers, receipts, or labels. These can serve as evidence in a legal claim.
3. Request medical records. Documentation of your child’s diagnosis, treatment, and recovery is essential for a successful legal case.
4. Avoid further use. Do not use any remaining ByHeart formula, even if it is unopened, as the FDA now considers all product lots potentially contaminated.
5. Consult with a product liability attorney. Legal counsel can help determine if you are eligible to file a lawsuit for medical expenses, pain, and other damages.

FAQs About ByHeart Baby Formula Lawsuits

What is the current status of the ByHeart recall?

The FDA has confirmed a recall of all ByHeart baby formula manufactured since March 2022 due to potential contamination linked to infant botulism. The company voluntarily pulled its products on November 11, 2025.

How many children have been affected?

As of December 2025, at least 51 infants in 19 states have been diagnosed with confirmed or suspected botulism after consuming ByHeart formula.

What are parents suing ByHeart for?

Lawsuits allege that ByHeart sold a defective and contaminated product, failed to ensure safe manufacturing, and did not adequately warn consumers. Plaintiffs are seeking compensation for medical costs, emotional harm, and punitive damages.

Does this affect all ByHeart formulas?

Yes. The FDA and CDC now advise that all lots of ByHeart formula may have been contaminated. Families are urged to discard any remaining product.

Is infant botulism deadly?

It can be. While no deaths have been reported in this outbreak, botulism can lead to respiratory failure, paralysis, and long-term developmental issues if not treated promptly.

How do I prove my child’s illness was caused by ByHeart?

You may need medical records confirming botulism, evidence your child consumed ByHeart formula, and lab results or packaging showing contamination or matching batch numbers. A product liability attorney can help build your case.

What is BabyBIG?

BabyBIG is the only treatment for infant botulism. It’s an IV immune therapy derived from adults immunized against the botulism toxin. It must be administered in a hospital setting and is available only through a California-based program.

Can I still sue if my child recovered?

Yes. Even if your child recovered, you may be eligible for compensation for medical bills, time off work, emotional stress, and the trauma your family endured.

Contact Parker Waichman LLP For A Free Case Review

If your child became sick after consuming ByHeart baby formula, you are not alone — and you may have a strong legal claim. The national product liability lawyers at Parker Waichman LLP are helping families nationwide hold manufacturers accountable for preventable harm.

We are currently reviewing infant botulism claims related to ByHeart and are offering free legal consultations to families who may be affected.

Call 1-800-YOUR-LAWYER (1-800-968-7529) now to speak with an attorney and learn your options. Parker Waichman LLP has recovered over $2 billion for injury victims. Let us fight for your child’s future. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.