Baby Formula Infant Botulism Lawsuit Lawyers

ByHeart Voluntarily Recalls Two Batches of Formula Sold at Target, Whole Foods, and Amazon Following Hospitalizations

Parents across the country are on high alert following the recall of two batches of baby formula manufactured by ByHeart. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have linked these batches to 13 reported cases of infant botulism in 10 different states. Each affected baby has required hospitalization, and while no deaths have occurred, the severity of this rare condition is prompting urgent warnings.

The recalled formula was distributed nationwide through major retailers, including Amazon, Whole Foods, and Target, placing thousands of families at potential risk. While ByHeart has claimed the recall is precautionary and that no products have tested positive for contamination, public health officials have confirmed that preliminary tests are showing signs of contamination in formula samples.

For parents who trusted this product, the impact of this recall goes beyond product replacement, it involves deep concern over their child’s health and the legal implications of corporate accountability.

Understanding Infant Botulism and Its Risks

Infant botulism is a serious and rare illness caused by the bacteria Clostridium botulinum. The bacteria can produce neurotoxins that attack the nervous system.

In babies under 12 months old, ingesting these spores can lead to life-threatening illness because their digestive systems are not fully developed. Once the spores multiply, the resulting toxins can interfere with nerve function, causing progressive weakness.

Symptoms of infant botulism include:

• Constipation (often the first symptom)
• Poor feeding or weak sucking
• Weak cry
• Loss of head control or limpness
• Drooping eyelids
• Trouble breathing or shallow respiration

Prompt treatment with botulism immune globulin (BabyBIG) is required to neutralize the toxins and help the infant recover. However, the hospitalization process is long and distressing for both child and family.

Details of the ByHeart Recall

On November 7, 2025, the FDA notified ByHeart of its connection to a multi-state botulism investigation. That same day, ByHeart issued a voluntary recall for two affected lots:

• Lot 251261P2
• Lot 251131P2
• Both carry a “Use by 01 Dec 2026” date

The company manufactures its products in Reading, Pennsylvania. The recalled formula was sold online and in physical retail locations across the country, including Amazon, Target, and Whole Foods.

While ByHeart has stated that no product tested positive for contamination at the time of the recall, the FDA and CDC confirmed that preliminary tests on the recalled formula were positive for Clostridium botulinum spores.

Who Are the Potential Victims Eligible to File a Lawsuit?

The impact of this recall reaches a broad group of individuals and families. Multiple parties may have valid claims under state and federal product liability laws.

Parents of Hospitalized Infants

The most direct victims are families whose babies developed botulism after consuming the recalled ByHeart formula. Every one of the 13 reported cases resulted in hospitalization. These families may pursue claims for:

• Medical bills
• Pain and suffering
• Emotional distress
• Lost income during hospitalization
• Future developmental or neurological issues related to the illness

Parents of Babies Who Consumed the Product but Are Asymptomatic

Even if a child hasn’t shown symptoms yet, families who purchased and fed their babies the affected formula may face emotional trauma, medical monitoring expenses, or psychological injuries stemming from fear and stress.

Families Who Discarded the Product and Suffered Financial Loss

While not the most severe category of harm, consumers who purchased the product and were forced to dispose of it may have valid claims under breach of warranty, especially if the replacement process was delayed, denied, or incomplete.

Potential Defendants Include:

• ByHeart, Inc. (the manufacturer)
• Retailers such as Amazon, Whole Foods, and Target (depending on state law)
• Distributors and logistic partners, if storage or transportation contributed to contamination
• Third-party testing labs, if they failed to detect contamination prior to distribution

Class action or mass tort litigation may also be considered if the number of affected families continues to grow.

Legal Grounds for Filing a Baby Formula Lawsuit

Consumers may have multiple legal pathways to seek justice and compensation, including:

Product Liability

Companies that make and sell products for infant consumption have a legal duty to ensure that those products are safe. When a product is contaminated with a dangerous pathogen, the manufacturer may be held strictly liable, regardless of intent.

Negligence

If the contamination was caused by improper manufacturing conditions, inadequate sterilization, or poor oversight, ByHeart could be held responsible for failing to exercise reasonable care.

Failure to Warn

Companies must warn consumers about known or foreseeable dangers. A delay in notifying the public or failure to disclose known risks may constitute grounds for liability.

Breach of Warranty

Families who purchased the product based on trust that it was safe for consumption may also pursue claims under express and implied warranty laws.

What Parents and Caregivers Should Do Now

If your child consumed the recalled ByHeart formula, take the following steps immediately:

• Stop feeding the product even if the child appears healthy
• Check the lot numbers to confirm whether your product was included in the recall
• Consult your pediatrician for advice or preventive care
• Seek emergency care if your child shows any symptoms of botulism
• Save all packaging and receipts for documentation
• Report symptoms to the FDA or your state’s health department
• Contact a personal injury attorney to understand your legal rights

Time-sensitive documentation and medical records can be essential to building a claim for compensation.

FAQs About the ByHeart Baby Formula Recall

What caused the recall of ByHeart baby formula?

The FDA and CDC linked two specific batches of ByHeart’s Whole Nutrition Infant Formula to 13 confirmed cases of infant botulism. Preliminary tests indicated the presence of Clostridium botulinum spores in product samples.

Which batches are affected?

Lot numbers 251261P2 and 251131P2, both with expiration dates of “Use by 01 Dec 2026,” are included in the recall. These products were sold nationwide.

What are the symptoms of infant botulism?

Symptoms include constipation, weak cry, poor feeding, droopy eyelids, loss of head control, and breathing difficulty. Immediate hospitalization is typically required to manage the condition.

Can parents sue if their child was hospitalized?

Yes. Families of infants who became sick after consuming the recalled formula can file product liability claims seeking compensation for medical expenses, long-term health impacts, and emotional trauma.

Do I need proof of purchase to file a claim?

Proof of purchase helps strengthen your claim, but other documentation, such as photos, medical records, or batch numbers from containers, may also support a lawsuit.

What if my baby consumed the product but didn’t get sick?

You may still have a claim if you incurred costs for medical screening, counseling, or emotional harm. Each case depends on its facts.

Will filing a lawsuit cost me anything upfront?

Parker Waichman LLP handles these claims on a contingency basis. That means you do not pay legal fees unless compensation is secured.

Contact Parker Waichman LLP For A Free Case Review

If your child was hospitalized or exposed to the recalled ByHeart infant formula, you may be entitled to significant compensation. Parker Waichman LLP is a national personal injury law firm currently investigating claims involving infant botulism linked to the ByHeart baby formula recall.

Call 1-800-YOUR-LAWYER (1-800-968-7529) now for a free and confidential consultation. Our attorneys are ready to review your case and help protect your family’s future. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.