ByHeart Baby Formula Recall Linked to Infant Botulism

FDA Confirms Contaminated Products Still Being Sold in Stores

The U.S. Food and Drug Administration (FDA) has confirmed a growing outbreak of infant botulism linked to ByHeart powdered baby formula, with at least 39 infants hospitalized across 18 states. Despite a national recall, the FDA says some stores are still selling the contaminated formula.

Infant botulism is a rare but extremely dangerous illness that can cause muscle paralysis, respiratory failure, and even death. Although no fatalities have been reported in this case, every one of the 39 affected infants required hospitalization, and some were admitted to intensive care.

The issue has caused national concern not only because of the seriousness of the illness, but also because some ByHeart formula products reportedly remain on store shelves at retailers like Walmart, Target, and Kroger weeks after the recall was announced.

Timeline and Scope of the Outbreak

Between August 9 and November 19, 2025, 39 confirmed or suspected cases of infant botulism were linked to ByHeart Whole Nutrition Infant Formula. The most recent illness was reported in mid-November. These cases occurred across the following states:

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

According to the FDA, all infants were under 6 months old and had consumed ByHeart formula prior to developing symptoms. The agency warned that formula from the recalled batches may still be on store shelves, and it continues to work with state agencies and retailers to enforce the recall and prevent further exposures.

Why ByHeart Formula Is Under Scrutiny

ByHeart accounts for a small portion of the U.S. formula market—approximately 1%—, but it distributes over 200,000 cans per month. Two specific batches of ByHeart Whole Nutrition Infant Formula have been officially recalled:

• Lot 206VABP/251261P2 (“Use by 01 Dec 2026”)
• Lot 206VABP/251131P2 (“Use by 01 Dec 2026”)

Although the company has stated that it acted promptly and voluntarily recalled the affected lots, consumers and legal advocates are questioning whether ByHeart and regulatory authorities responded quickly enough. In fact, multiple parents have come forward reporting botulism-like symptoms in their babies as far back as early 2024, months before the official recall.

Infant Botulism Explained

Toxins produced by Clostridium botulinum bacteria cause infant botulism. These toxins can paralyze muscles and disrupt breathing. Infants are especially vulnerable because their digestive systems are still developing and may not be able to prevent the bacteria from growing in the gut.

Common symptoms of infant botulism include:

• Weak crying or sucking
• Poor feeding
• Floppy limbs or head
• Drooping eyelids
• Difficulty breathing

The only approved treatment in the United States is an intravenous antitoxin that costs over $69,000 per dose. Every infant affected in this outbreak has required this medication, according to the Centers for Disease Control and Prevention (CDC).

Parents Say Illnesses Began Months Before Recall

Families in California and other states are raising concerns that ByHeart’s products may have been contaminated long before the official recall began.

Amy Mazziotti of Burbank, California, reported that her 5-month-old son, Hank, was hospitalized for botulism in March 2025—five months before the recall. She now believes the ByHeart formula he consumed was the cause. While the California Department of Public Health says there is no clear connection to the current outbreak, investigators confirmed that unopened cans of ByHeart formula tested positive for Clostridium botulinum.

Adding to the concern, some cans linked to sickened infants caused rapid illness in laboratory mice during testing—a strong indication of dangerous contamination levels.

FDA’s Continued Efforts to Prevent Further Exposure

On December 3, the FDA issued a statement acknowledging that some ByHeart products remain on store shelves, despite the nationwide recall. The agency confirmed that it is working with major retailers and state-level partners to remove any remaining products from circulation.

All forms of ByHeart formula, both cans and single-serve packets, have been recalled. Parents who still possess any of the recalled products are urged to stop using them immediately and discard them.

Operation Stork Speed: A New Push for Safety

As part of its response to the botulism outbreak and broader concerns over formula safety, the FDA has launched Operation Stork Speed—an initiative aimed at increasing testing of infant formula for toxic substances, including:

• Arsenic
• Lead
• Mercury
• Pathogenic bacteria

This effort reflects a growing national awareness of the risks posed by contaminated infant formula. Earlier incidents, such as the Abbott Nutrition recall in 2022, triggered major shortages and national debate over formula safety. The FDA’s new testing measures are designed to detect contamination before widespread harm occurs.

Legal Ramifications for ByHeart

With multiple infants hospitalized and medical bills exceeding tens of thousands of dollars, families are beginning to explore legal action. Potential lawsuits could be based on:

• Product Liability: If the formula was contaminated during manufacturing or packaging, ByHeart may be held responsible for injuries.
• Failure to Warn: If ByHeart was aware of contamination risks and did not issue timely warnings, this could be grounds for legal claims.
• Negligence: Inadequate safety protocols or slow response to contamination reports may qualify as negligent behavior.
• Wrongful Injury: Families of infants who suffered long-term complications or significant hospitalization may seek compensation for pain, suffering, and future medical care.

Legal claims may be strengthened by evidence that some babies were hospitalized months before the public was notified or the recall was issued. Lawsuits could help families recover medical expenses and hold manufacturers accountable for unsafe practices.

Consumer Actions and Next Steps

Parents and caregivers should immediately check their homes for any recalled ByHeart formula. If any cans match the affected lot numbers, they should be discarded safely. Photos of the cans, receipts, and medical records related to a baby’s illness may be crucial if a legal claim is pursued.

Families whose infants showed symptoms of botulism or required hospitalization after consuming ByHeart formula should consider speaking with a product liability attorney to evaluate their options.

Infant Botulism and ByHeart Formula Lawsuit FAQs

What is infant botulism, and how serious is it?

Infant botulism is a rare bacterial illness caused by Clostridium botulinum. It can result in severe paralysis, breathing difficulties, and death if untreated. It is a medical emergency requiring immediate hospitalization and antitoxin treatment.

What symptoms should parents watch for in infants?

Symptoms include weak feeding, drooping eyelids, muscle weakness, reduced movement, weak crying, and difficulty breathing. If your baby displays these signs after using formula, seek medical help immediately.

What formula products have been recalled?

ByHeart Whole Nutrition Infant Formula, Lot numbers 206VABP/251261P2 and 206VABP/251131P2, with “Use by 01 Dec 2026,” have been recalled due to contamination concerns.

Are these recalled products still being sold?

Yes, according to the FDA, some retailers have not yet removed all recalled products. Consumers have reported finding them at stores like Target, Walmart, Kroger, and others.

Can I sue if my child got sick from ByHeart formula?

Yes. If your child became ill after using ByHeart formula, you may be able to file a lawsuit for product liability, medical costs, and emotional distress. An attorney can help determine your legal options.

What kind of compensation could I receive?

Compensation may include hospital bills, future medical care, pain and suffering, lost wages for parents, and costs related to long-term complications.

Is there a time limit to file a claim?

Yes. Each state has a statute of limitations for product liability and injury cases. It’s important to act quickly to preserve your rights.

Is there help available to cover treatment costs?

Families may be eligible for financial compensation through legal action. BabyBIG treatment alone can cost over $69,000 per dose.

Contact Parker Waichman LLP For A Free Case Review

If your child became sick after consuming ByHeart baby formula, you may be entitled to significant financial compensation. At Parker Waichman LLP, our legal team is currently investigating claims on behalf of families harmed by contaminated infant formula.

You should not have to face this crisis alone. Let us help you pursue justice and hold those responsible accountable.

Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation today. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you. Our national product liability attorneys are here to support your family and fight for the compensation you deserve.