ByHeart Formula Recall Lawsuit

The recall of ByHeart powdered infant formula has become a pivotal moment in U.S. product-safety and infant health because it involves a very rare disease, infant botulism, linked to formula that normally would not be expected to carry such a risk.

The national inquiry began when the California Department of Public Health and federal agencies flagged that one previously opened can of ByHeart Whole Nutrition Formula tested positive for spores of Clostridium botulinum, the bacterium that produces a neurotoxin causing paralysis in babies.

Although infant botulism is exceedingly rare and historically associated with environmental exposures (not formula), this outbreak triggered a broad voluntary recall of all ByHeart Whole Nutrition Infant Formula products sold nationwide, including both cans and single-serve “Anywhere Pack” pouches.

The fact that no other infant formula brands have been implicated thus far, despite the ongoing investigation, makes this incident unique and deeply concerning.

The Food and Drug Administration (FDA) is coordinating with the Centers for Disease Control and Prevention (CDC) and state health partners to trace how powdered infant formula exposure may have allowed C. botulinum spores to germinate and produce toxin in vulnerable infants.

ByHeart represents only about 1 % of U.S. infant formula sales yet is disproportionately represented among sick infants.

Parents and caregivers of infants who consumed this specific powdered infant formula are being urged to immediately discontinue use and monitor for warning signs of illness.

Below is a timeline of events related to the ByHeart formula recall:

• Mid-August 2025: First hospitalizations of infants with suspected or confirmed infant botulism following consumption of ByHeart formula.
• November 8, 2025: ByHeart issues initial voluntary recall of two specific lots of its Whole Nutrition Infant Formula.
• November 11, 2025: Recall expanded to include all unexpired lots of ByHeart Whole Nutrition infant formula (including powder cans and Anywhere Pack pouches) nationwide.
• November 14, 2025: CDC and FDA report 23 infants in 13 states hospitalized with suspected or confirmed infant botulism after using ByHeart formula; no deaths reported to date.
• November 19, 2025: FDA/CDC revised count is 31 infants in 15 states with confirmed exposure to ByHeart formula; all hospitalized; no deaths reported.
• Currently: As of November 24, 2025, 31 infants have been hospitalized after consuming ByHeart formula across 15 states (no deaths reported).
  • FDA reports 84 infant botulism cases detected since August, of which a significant share consumed powdered formula (with ByHeart disproportionately represented).
  • ByHeart begins batch-by-batch third-party testing, gives full facility access to regulators, and advises parents to stop use immediately.
  • Agencies urge “immediately discontinue use” of any ByHeart powdered infant formula and to seek immediate medical attention for infants showing possible symptoms.

Infant botulism is a severe, life-threatening condition in babies whose guts are not yet able to handle C. botulinum spores, and this outbreak potentially represents the first confirmed link between formula exposure and such illness.

Historically, powdered infant formula has faced microbial risk (e.g., Cronobacter), but the possibility of toxin-producing spores in formula elevates the threat to a new level of urgency.

Because infants are uniquely vulnerable, the speed of hospitalization in affected babies and the need for specialized treatment (such as antitoxin) underscore the high stakes.

Regulatory gaps in monitoring and microbial control of powdered infant formula are now under intense review, and manufacturers of other infant formula brands are likely paying attention.

For affected families, the disruption extends beyond immediate illness.

Long hospital stays, respiratory support, developmental monitoring, and emotional trauma are all possible outcomes.

As such, this recall and investigation demand swift, informed action from caregivers, health professionals, and lawyers alike.

What ByHeart Brand Formula Has Been Recalled?

The recall of the ByHeart baby formula centers on its Whole Nutrition Infant Formula line, specifically both the 24 oz cans and the single-serve Anywhere Pack™ powdered infant formula products.

The company initially recalled two specific batches (lot codes 206VABP/251261P2 and 206VABP/251131P2, Use by 01 Dec 2026) after epidemiologic and laboratory data linked infants who consumed these formulas to confirmed or suspected infant botulism cases.

Following additional findings from federal and state health authorities, ByHeart expanded the recall on November 11, 2025 to include all unexpired batches of its Whole Nutrition Infant Formula sold nationwide.

The FDA’s updated recall notice confirmed that an opened can from one of the recalled lots tested positive for Clostridium botulinum spores, though no unopened cans have yet tested positive.

The expansion was conducted in cooperation with the Food and Drug Administration (FDA) and the California Department of Public Health, with ByHeart granting investigators full access to its facilities and committing to independent third-party laboratory testing of all product batches moving forward.

Recalled ByHeart product(s):

• ByHeart Whole Nutrition Infant Formula – 24 oz cans (UPC 85004496800) – all unexpired batches nationwide.
• ByHeart Whole Nutrition Infant Formula – Anywhere Pack™ single-serve sticks (UPC 85004496802) – all unexpired batches nationwide.

If you have any of these ByHeart powdered infant formula products, it is important that you immediately discontinue use and securely dispose of the formula, while monitoring your child for any symptoms of infant botulism and seeking medical attention if needed.

How Many Cases of Infant Botulism Linked to ByHeart Formula Have Been Reported?

The number of infant patients reported in connection with the ByHeart powdered formula investigation has grown as the outbreak evolves.

According to the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), approximately 13 infants across 10 U.S. states were initially hospitalized after consuming ByHeart Whole Nutrition formula.

More recently, updates show the total has increased to 31 infants in more than a dozen states, all of whom had exposure to ByHeart brand powdered infant formula.

These infant patients represent a disproportionately high share of cases in this outbreak of infant botulism linked to powdered formula exposure.

The FDA reports that of about 84 total infant botulism cases under investigation since August 2025, 36 involved powdered formula, and more than 40% of those consumed ByHeart formula.

All of the affected infants were hospitalized, though no deaths have been reported to date.

Is ByHeart Facing Lawsuits Over the Formula Recall?

ByHeart is now the subject of active legal claims following the nationwide recall of its powdered infant formula after a documented outbreak of infant botulism.

According to a report by CBS News, two federal lawsuits were initially filed by parents of four-month-old daughters, one in Arizona and one in Kentucky, who were diagnosed with botulism after consuming the company’s product.

The complaints allege that the ByHeart formula the infants consumed was defective, and that ByHeart was negligent in manufacturing and selling it despite epidemiologic and laboratory data linking the product to illness.

According to one parent’s account, her child had consumed an entire can of the recalled ByHeart powdered formula just one day before the recall was publicly announced.

ByHeart acknowledged the recall and expressed sympathy for the families affected, but stated they “would address any legal claims in due course.”

Now, at least five separate lawsuits have been filed against ByHeart, including a proposed class action lawsuit.

The class action claims that parents were misled by marketing which positioned the formula s a premium “healthy alternative”, when in reality the formula was defective and the company failed to ensure safe manufacturing and testing.

ByHeart’s Response and Growing Scrutiny Over Manufacturing Safety

Reporting from STAT shows that ByHeart’s early statements downplayed the link between its formula and the infant botulism cases, even as health officials connected multiple hospitalizations to the product.

The company initially pointed to negative tests from unopened cans, but experts note that powdered formula contamination can appear inconsistently and may not be detected in every sample.

The FDA later confirmed that an opened can had tested positive for Clostridium botulinum spores, which led to the expanded recall covering all unexpired lots of ByHeart Whole Nutrition Infant Formula.

This incident follows earlier issues with ByHeart’s production oversight.

In December 2022, the company recalled five batches of its formula due to potential Cronobacter sakazakii contamination.

In August 2023, the FDA issued a formal Warning Letter citing failures in ByHeart’s microbial controls, environmental monitoring, and record-keeping , including findings that formula with potential contamination risks had been distributed commercially.

With the current outbreak linked to ByHeart products, regulators are reviewing the company’s manufacturing processes, sanitation controls, and testing methods across multiple years of operations.

The FDA has gained full access to ByHeart’s facilities, and the company has begun batch-by-batch third-party testing as part of the ongoing investigation.

These documented issues, combined with the formula-linked botulism cases, are now a central focus in evaluating whether preventable safety failures contributed to the outbreak.

The current investigation centers on how a product (ByHeart Whole Nutrition Infant Formula) sold nationwide may have exposed babies to a very rare disease: infant botulism.

What makes this situation unique is that infant botulism historically arises from environmental exposures (such as honey or soil), not from powdered infant formula, yet epidemiologic and laboratory data are pointing to this specific powdered formula exposure.

Federal and state health department officials say the recall followed identification by a state public‐health laboratory and an independent third-party laboratory that cans of the formula may contain spores of the toxin‐producing bacteria Clostridium botulinum, which can generate the potent botulinum toxin inside an infant’s gut.

The fact that ByHeart’s brand represents less than 1 % of U.S. infant formula sales, yet is disproportionately represented among sick infants, raises urgent questions about manufacturing, quality control, and regulatory oversight.

The Food and Drug Administration (FDA) and state health agencies are actively investigating how these spores may have entered the production or packaging chain of this powdered infant formula.

Because the affected infants are among the most vulnerable population and the disease can lead to severe medical outcomes including paralysis and respiratory compromise, the stakes are extremely high.

The recall and investigation spotlight failures in a category of products long regarded as tightly regulated and safe, creating both public-health and liability ramifications.

For families of affected infants, this is not simply a product recall.

It is an unfolding medical and safety crisis tied to infant feeding.

What are the Symptoms of Infant Botulism?

Infant botulism is a serious condition where toxin-producing bacteria colonize an infant’s gut, and illness onset can be gradual but rapidly escalate.

Ill infants initially develop constipation, reflecting initial interference with gut motility.

As the disease progresses, infants may show poor feeding and weakness in their muscle tone, including head control difficulty and a weak and altered cry.

Trouble swallowing and difficulty breathing can follow, as the botulinum toxin begins to disable nerve-to-muscle signaling, and in severe cases respiratory arrest is possible.

Because powdered formula exposure has been implicated in recent outbreaks and infants can’t verbalize their symptoms, caregivers must remain vigilant and seek immediate medical attention if any red flags appear.

Common symptoms to monitor in infants:

• Constipation (often the very first noticeable sign)
• Difficulty feeding, decreased sucking strength, or refusal to eat
• Weak and altered cry, diminished facial expression, progressive muscle weakness (especially in arms, legs, neck)
• Difficulty swallowing, excessive drooling or pooling of oral secretions
• Trouble breathing or respiratory difficulty up to potential respiratory arrest in severe cases

If an infant has been exposed to a recalled product or is showing any of these symptoms, timely medical care is critical.

What are the Potential Long-Term Health Consequences of Infant Botulism?

While prompt treatment of Infant botulism (the rare paralysis-causing illness in babies) greatly improves outcomes, serious long-term health consequences remain possible and cannot be overlooked.

When the toxin-producing bacterium Clostridium botulinum spores colonize a baby’s immature gut, they produce botulinum toxin inside the body, which disrupts nerve-to-muscle signaling and can lead to neuromuscular paralysis.

Survivors may face prolonged recovery periods including muscle weakness, hypotonia (low muscle tone), and delayed motor-skill development.

In severe cases where respiratory muscles were involved, infants may require extended ventilatory support and rehabilitation, and some literature suggests that full recovery of strength may take up to a year or more.

Although older data suggest most infants recover without major residual deficits, the fact that toxin remains in the stool for weeks or months and that monitoring for developmental milestones is necessary means long-term follow-up is still recommended.

Importantly, because the current outbreak involves potential exposure through contaminated powdered infant formula (such as the ByHeart product sold nationwide), families and clinicians must remain alert for any late-emerging health issues and document any developmental or neuromuscular concerns as part of comprehensive care and legal evaluation.

Known or potential long-term consequences include:

• Slower recovery of muscle strength and nerve-to-muscle function. Improvement is greatest during the first 3 months, with possible residual weakness after a year.
• Delays in motor-skills milestones (sitting, crawling, walking) due to earlier neuromuscular impairment in an infant’s critical developmental window.
• Prolonged need for physical therapy or other rehabilitative support if the illness involved significant muscular or respiratory compromise.
• Potential for respiratory or feeding complications post-hospitalization, especially if respiratory muscles were affected during the acute illness.
• Psychological and emotional impacts on families and infants from extended hospitalization, developmental monitoring and ongoing healthcare needs.

Given the evolving nature of current infant botulism clusters and the unprecedented link to a major powdered infant formula brand, continuous tracking of health status, developmental progress and neuromuscular function is strongly advised for affected infants.

Infant Botulism Treatment Options

Treatment for infant botulism must begin immediately once the condition is suspected.

Waiting for laboratory confirmation is not advised.

Here’s an overview of the main treatment strategies:

• Botulism immune globulin (BabyBIG®): This human-derived antitoxin is the standard therapy for infant botulism. It works by neutralizing unbound botulinum toxin, helping prevent further nerve damage.
• Supportive care in a hospital setting: Expect intensive monitoring, especially of airway and breathing functions. Mechanical ventilation may be necessary if respiratory muscles are compromised.
• Feeding and nutrition support: Infants often have difficulty feeding and swallowing; enteral nutrition or NG-tube feeding may be used until swallowing reflexes recover.
• Neuromuscular and physical therapy: Because infants may suffer muscle weakness and delayed motor development, early therapy and rehabilitation are key for better long-term outcomes.

Because the toxin causes damage that cannot be reversed (antitoxin cannot undo bound toxin), the goal of treatment is to stop further damage and provide intensive supportive care until the infant’s neuromuscular system recovers.

Early recognition, prompt administration of BabyBIG® and expert supportive care dramatically improve recovery times and reduce complications.

Families may qualify for the ByHeart formula lawsuit if their child developed symptoms of infant botulism after consuming recalled ByHeart formula nationwide.

Eligibility typically depends on medical records confirming exposure to the recalled product and a clinical diagnosis of infant botulism.

Because symptoms develop gradually, often beginning with constipation, poor feeding, and muscle weakness, many parents did not initially suspect a contaminated product.

Infants who later tested positive for Clostridium botulinum exposure or required hospitalization after consuming ByHeart formula may have valid claims.

Legal claims may include compensation for medical costs, extended hospital stays, long-term rehabilitation, and emotional distress caused by the illness.

Families who purchased or used recalled lots of ByHeart Whole Nutrition Infant Formula or Anywhere Pack single-serve sticks may also be eligible for refund or replacement claims even if illness did not occur.

Documentation such as lot numbers, purchase receipts, or medical evaluations strengthens the basis for a lawsuit.

TorHoerman Law is reviewing potential claims from parents across the country to determine whether their infant’s illness may be linked to the recalled ByHeart formula nationwide.

Gathering Evidence for Infant Botulism Cases

Proving a connection between recalled formula and a child’s illness requires clear, well-documented evidence.

Medical and product records play a crucial role in establishing that an infant consumed a specific recalled ByHeart formula and later developed symptoms consistent with infant botulism.

Because the disease is rare and highly specific, both laboratory testing and detailed caregiver accounts help support causation.

Families pursuing legal action should gather and preserve all available evidence before discarding any recalled products.

Evidence to gather for an infant botulism case:

• Unopened or partially used cans or pouches of recalled ByHeart formula for potential laboratory testing.
• Lot codes, expiration dates, and packaging photos showing the exact product involved.
• Purchase receipts, order confirmations, or retailer statements verifying where and when the formula was bought.
• Medical records and lab results documenting diagnosis, hospitalization, and treatment of infant botulism.
• Physician or public health correspondence confirming a link between the illness and formula exposure.
• Communication with ByHeart or the FDA regarding recall notifications or replacement/refund requests.
• Caregiver notes or symptom timelines showing when symptoms developed after the child consumed the formula.

Damages and Potential Compensation in ByHeart Lawsuits

Damages in ByHeart formula lawsuits represent the financial and emotional losses suffered by families whose infants developed botulism after consuming the recalled product.

Lawyers assess these damages by reviewing medical records, hospitalization costs, and long-term care needs to determine the full impact of the illness on a child’s health and family stability.

Experienced product liability attorneys also calculate non-economic damages, such as pain, suffering, and emotional distress, to pursue maximum compensation through settlement or trial.

In severe cases, lawyers may also evaluate the potential for punitive damages if evidence suggests negligence or manufacturing failures.

The goal is to secure financial relief that helps families recover from both the immediate and ongoing consequences of infant botulism.

Damages that may be recovered in ByHeart lawsuits:

• Medical expenses for hospitalization, ventilatory support, and specialized treatment.
• Rehabilitation and therapy costs for muscle weakness or developmental delays.
• Future medical monitoring for respiratory or neuromuscular complications.
• Emotional distress and loss of quality of life for both the infant and family members.
• Lost income or caregiving expenses for parents who had to leave work.
• Pain and suffering related to the child’s illness and prolonged recovery.
• Punitive damages if evidence shows reckless disregard for infant safety.

The ByHeart formula recall has left many families searching for answers and accountability after their infants were exposed to a preventable, life-threatening illness.

As investigations continue, TorHoerman Law is committed to uncovering the truth behind how contaminated formula reached store shelves and holding those responsible accountable for the harm caused.

Our firm has extensive experience in complex product liability and infant injury cases, allowing us to pursue justice and fair compensation for affected families.

Every case matters, and every child impacted by this outbreak deserves a thorough legal review and dedicated advocacy.

If your child developed symptoms of infant botulism after consuming recalled ByHeart formula, contact TorHoerman Law today for a free and confidential case evaluation.

Our legal team is reviewing claims nationwide and can help you understand your rights, gather evidence, and pursue compensation for the damages your family has endured.

You can also use the chat feature on this page for a free and confidential case evaluation.