Dangerous Recalled ByHeart Infant Formula Sold at Major Stores: What Parents Need to Know and Legal Options Available

Parents and Caregivers Seek Justice After FDA Finds Dangerous Recalled Baby Formula Sold at Target, Walmart, Kroger, and Albertsons

In late 2025, the U.S. Food and Drug Administration (FDA) issued urgent warning letters to national retailers, including Target, Walmart, Albertsons, and Kroger, after discovering that dangerous, recalled infant formula products remained on store shelves well after the recall was initiated. This alarming situation emerged during a multi‑state recall of ByHeart Whole Nutrition Infant Formula, which has been linked to a cluster of infant botulism cases.

According to the Centers for Disease Control and Prevention (CDC), at least 51 infants in 19 states developed botulism after being fed the contaminated formula. Botulism is a rare but life‑threatening condition that attacks the nervous system and can lead to paralysis or death if not recognized and treated promptly. The fact that recalled products continued to be sold despite multiple recalls and notifications has raised serious concerns about corporate compliance, product safety, and the effectiveness of recall enforcement in the supply chain.

For families who trusted these products to nourish their infants, the FDA’s warnings signal a breakdown in oversight that may have contributed to preventable injuries. If your child became ill after consuming recalled infant formula or if you purchased formula that was sold past recall notices, and you may have legal options. Understanding the recall, the risks involved, and your rights under product liability law is essential for protecting your family and pursuing compensation.

What Happened: Babies Sickened After Eating Recalled ByHeart Formula

The recall began in August 2025 after public health agencies identified a cluster of infant botulism cases tied to ByHeart Whole Nutrition Infant Formula. Botulism in infants is caused by the bacteria Clostridium botulinum, which produces a potent nerve toxin. Unlike most foodborne illnesses, infant botulism can occur when infants ingest spores that then germinate in the gut, producing toxin internally.

Symptoms of infant botulism can be subtle at first but become severe rapidly. They include:

• Constipation
• Poor feeding or refusal to suck
• Weak cry
• Drooping eyelids
• Slow or reduced muscle tone
• Difficulty swallowing or sucking
• Generalized weakness
• Respiratory distress or arrest

The FDA, CDC, and state health departments launched investigations after reports of these symptoms and laboratory confirmation of botulism in affected infants. Public health alerts were issued, and ByHeart expanded its recall to include additional lots as more information emerged.

The recall was intended to remove all potentially contaminated formula from the supply chain and prevent further cases. However, subsequent FDA inspections and consumer reports revealed that recalled formula was still being sold in stores months after the recall commenced.

FDA Warnings to National Retailers: Failure to Remove Recalled Formula

In December 2025, the FDA sent formal warning letters to major retail chains after confirming that recalled infant formula remained available for purchase in multiple states. The warning letters emphasized that retailers have an obligation to take immediate action once they are notified of a recall or safety issue.

The retailers named in the warning letters include:

• Target – Recalled formula present in at least 20 stores, sometimes even with promotional signage.
• Walmart – Affected products found on shelves in 21 states.
• Albertsons and Jewel‑Osco – Recalled products found in 11 states.
• Kroger‑owned stores – Recalled product present in 10 states.

In each case, the FDA advised the company to provide a written response within 15 days, detailing the steps taken to address the violations and ensure recalled products are removed from distribution and sale.

The letters noted several reasons offered by store associates for why recalled formula remained on shelves, including:

• Confusion over which product lots were affected.
• Lack of awareness of the recall notice.
• Failure to remove all impacted inventory.
• Mistaken restocking of recalled products after initial removal.

Selling recalled products poses significant dangers, especially when the products are intended for infants—a population that is uniquely vulnerable to contaminants and infection.

What Infant Botulism Is and Why It Matters

Infant botulism is a serious medical condition caused by toxins produced by Clostridium botulinum bacteria. Unlike botulism in adults, which usually results from ingestion of preformed toxin, infant botulism occurs when spores are ingested and grow within the infant’s digestive tract.

Infants under 12 months are particularly susceptible because their gut microbiome is not yet fully developed. Once spores germinate, they produce toxins that block nerve function, leading to flaccid paralysis.

Medical professionals describe infant botulism as a condition that requires immediate attention. Early symptoms can be easily mistaken for more common infant behaviors, but progression can be rapid:

• Constipation often precedes other symptoms.
• Poor feeding and lethargy can be misattributed to routine digestive issues.
• Weak muscle tone and difficulty breathing are medical emergencies.

Treatment usually involves hospitalization, administration of botulism antitoxin, and supportive care. Recovery can be prolonged, and some infants require weeks of intensive care.

Because botulism is rare, many pediatricians do not see cases frequently, making early recognition and lab testing critical to diagnosis. Parents who suspect symptoms should seek medical care immediately.

Impact on the Infant Formula Supply and Broader Public Health

Although ByHeart products account for less than 1 percent of the total infant formula market in the United States, the recall has drawn national attention due to the severity of the illnesses and the vulnerability of the affected population.

The FDA has stated that this recall is not expected to affect overall formula supply nor contribute to widespread shortages. However, the situation underscores ongoing concerns about the safety of infant nutrition products and the effectiveness of recall enforcement.

Since August 2025, the FDA has received 83 reports of botulism potentially tied to infant formula products. While public health agencies have not yet released the names of other brands involved, the volume of reports suggests that investigations are ongoing.

Parents and caregivers across the nation have responded with alarm as information evolves, highlighting intense anxiety about the safety of baby formula and the adequacy of supply chain monitoring.

Legal Rights for Families Affected by Recalled Infant Formula

When a consumer product causes serious illness or death, the law allows injured parties to pursue compensation under product liability and related legal theories. Families affected by botulism linked to recalled infant formula may have grounds for legal action if:

• A loved one consumed formula that was recalled but still sold in stores.
• The recalled product caused injury, hospitalization, or long‑term health problems.
• There is evidence that retailers failed to remove recalled products despite warnings.
• The manufacturer did not provide adequate safety testing or timely recall communication.

Product liability claims may be based on several legal theories:

1. Defective Design – The formula contained harmful contaminants due to unsafe formulation.
2. Failure to Warn – Manufacturers and retailers did not adequately warn caregivers about risks or recall details.
3. Negligence – Parties in the supply chain failed to exercise reasonable care in removing dangerous products.
4. Strict Liability – Manufacturers and distributors can be held responsible for putting a dangerous product into circulation, regardless of intent.

In product liability cases, families may seek compensation for:

• Medical expenses, including emergency care, hospitalization, surgery, medications, therapy, and follow‑up treatments.
• Lost income for parents who missed work to care for their child.
• Pain and suffering endured by infants and families.
• Long‑term care costs if neurological or developmental complications arise.
• Funeral and burial costs in wrongful death cases.

Litigation in these matters may involve multiple parties, including formula manufacturers, distributors, and potentially retailers who failed to remove recalled products after being notified.

How to Know If Your Family Has a Claim

You may have a legal claim if:

• Your child was diagnosed with botulism after consuming baby formula.
• You purchased infant formula that was later recalled but continued to be sold.
• You have medical records showing symptoms consistent with botulism after formula use.
• You were unaware of the recall but purchased the product due to store availability.
• Your child required hospitalization or long‑term care due to formula‑related illness.

Important evidence in these cases may include:

• Receipts or proof of purchase for recalled formula.
• Photographs of product packaging and lot numbers.
• Medical records, lab reports, and doctor diagnoses.
• Hospital discharge summaries and bills.
• Records showing retailer location and date of purchase.

Documenting this information as soon as possible strengthens any potential claim and helps legal counsel assess your case accurately.

Preventing Future Harm: What the Public Can Learn

The FDA’s warning letters highlight systemic weaknesses in how recalls are carried out and enforced across the retail supply chain. The fact that dangerous formula remained on shelves despite official recall notices reveals gaps in communication, training, and compliance among national retailers.

Parents should always review product lot numbers against official recall lists available on the FDA’s recall database and take immediate action if a match is found. In addition, reporting suspected cases of foodborne illness to public health authorities can help accelerate investigations and protect others.

Infant Formula Botulism Lawsuits Frequently Asked Questions (FAQs)

What formula was recalled?
The recall targeted ByHeart Whole Nutrition Infant Formula after public health agencies linked it to multiple cases of infant botulism.

Why is the formula dangerous?
The product was linked to contamination with Clostridium botulinum, a bacterium that produces toxins that attack the nervous system and can cause paralysis in infants. Symptoms can be severe and life‑threatening.

Which stores were selling the recalled formula?
The FDA warned that recalled formula was still found on shelves at Target, Walmart, Albertsons (including Jewel‑Osco), and Kroger‑owned stores in multiple states, even after recall notices had been issued.

How do I know if I bought recalled formula?
Check the lot number and recall notices on the FDA’s official recall website. If the lot matches recalled products, discontinue use immediately and safely dispose of remaining formula.

What symptoms should I watch for?
Watch for constipation, poor feeding, drooping eyelids, weak cry, low muscle tone, trouble swallowing, or respiratory difficulty. Seek medical care immediately if symptoms appear.

Can I file a lawsuit if my baby got sick?
Yes. Families whose children were sickened by recalled formula may have legal claims for medical costs, pain and suffering, lost income, and other damages.

What compensation is available?
Potential compensation includes medical bills, hospital stays, therapy costs, lost wages, long‑term care needs, and, in some cases, wrongful death damages.

Is there a time limit to file a claim?
Yes. Each state has deadlines (statutes of limitation) for filing product liability claims. Contact a lawyer promptly to protect your rights.

Do I need evidence?
Yes. Receipts, packaging photos, medical records, and documentation of retailer location and purchase date are useful for building a claim.

Can retailers be held liable?
Possibly. If retailers continued selling recalled formula after receiving notice, they may share liability along with manufacturers and distributors.

Contact Parker Waichman LLP For A Free Case Review

If your baby was sickened after consuming recalled infant formula or if you purchased dangerous formula that remained on shelves despite recall notices, you may have legal rights. Parker Waichman LLP is a national personal injury law firm representing families nationwide in defective product and food contamination cases.

Call 1‑800‑YOUR‑LAWYER (1‑800‑968‑7529) today for a free consultation to review your case, understand your options, and pursue the compensation your family deserves. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you. Time limits to file a claim may apply, so prompt legal action is important.