A rare and serious outbreak of infant botulism has led to a voluntary recall of specific batches of ByHeart Whole Nutrition Infant Formula, following an investigation by federal health agencies. The outbreak has resulted in the hospitalization of 13 infants across ten states, though no deaths have been reported.
This developing situation is notable because, if confirmed, it would mark an unprecedented event in the U.S., as there is no historical precedent of infant formula causing botulism, according to a statement from ByHeart in their recall notice. Health officials and the company have stressed the importance of immediate action for parents and caregivers who may have the affected batches in their homes.
The Scope of the Outbreak
As of November 8, 2025, public health officials have identified 13 cases of infant botulism linked to the recalled formula. The infants, who range in age from 16 to 157 days, became ill over a period spanning from mid-August to November 2025. All of the affected infants required hospitalization and were treated with BabyBIG®, an antitoxin that is the standard treatment for this illness.
The cases are geographically dispersed, affecting infants in ten different states. The following table outlines the distribution of reported cases:
| State | Number of Reported Cases |
| Arizona | 1 |
| California | 2 |
| Illinois | 2 |
| Minnesota | 1 |
| New Jersey | 1 |
| Oregon | 1 |
| Pennsylvania | 1 |
| Rhode Island | 1 |
| Texas | 2 |
| Washington | 1 |
Case distribution based on data from the Centers for Disease Control and Prevention (CDC).
The epidemiological investigation, which involved interviews with caregivers, revealed that all 13 infants had been fed ByHeart Whole Nutrition infant formula before becoming sick. This consistent finding across all cases prompted the FDA to recommend a voluntary recall.
In parallel with the case investigation, officials in several states have gathered un-used portions of the infant formula for laboratory analysis. These tests are currently in progress, with results anticipated within the next few weeks.
The Recall: Specifics and Consumer Action
On November 8, 2025, ByHeart Inc. agreed to a voluntary recall of two specific lots of its Whole Nutrition Infant Formula. The company has emphasized that this action was taken “out of an abundance of caution” and that no contaminants have been detected in its products through its own testing or that of regulatory agencies.
The recalled products are identified with the following details :
- Product Name: ByHeart Whole Nutrition Infant Formula
- Affected Lots: 206VABP/251261P2 and 206VABP/251131P2
- Use-By Date: December 1, 2026
- UPC Code: 5004496800
The lot code and use-by date can be found printed on the bottom of the formula can.
Steps for Consumers to Take
Federal health authorities have issued guidance for parents and caregivers :
- Stop Using the Formula: Immediately discontinue use of any formula from the recalled lots.
- Dispose or Return: Either throw the product away or return it to the place of purchase.
- Record the Lot Number: If possible, note the lot number before disposing of the product.
- Clean Thoroughly: Wash and sanitize all bottles, nipples, and surfaces that may have come into contact with the recalled formula using hot, soapy water or a dishwasher.
- Seek Medical Attention: Contact a healthcare provider immediately if an infant has consumed the recalled formula and is showing any symptoms of botulism.
For concerned consumers, ByHeart has set up a 24/7 customer service line at 1 (833) 429-4327 and a dedicated email at [email protected]. The company has also stated it will replace recalled cans and provide two additional cans at no cost to affected customers.
Understanding Infant Botulism
Infant botulism is a rare but serious illness caused by the bacterium Clostridium botulinum. In this unique form of the disease, an infant ingests the bacterial spores, which then colonize the immature intestinal tract and produce a neurotoxin. This is different from foodborne botulism in adults, which is typically caused by eating food that already contains the pre-formed toxin.
Infants younger than one year are particularly vulnerable because their gut microbiome is not yet developed enough to compete with and prevent the growth of C. botulinum. The illness can be life-threatening as the toxin attacks the body’s nerves, leading to muscle weakness and paralysis.
Recognizing the Symptoms
The CDC advises parents to be vigilant for the following signs and symptoms, which can take days or even weeks to develop after exposure :
- Early Signs: Constipation, poor feeding, and loss of head control.
- Progressive Weakness: A weak cry, decreased facial expression, droopy eyelids, difficulty swallowing, and a general loss of muscle tone, making the infant appear “floppy.”
- Severe Complications: If untreated, the paralysis can progress to breathing difficulties, requiring mechanical ventilation and lengthy hospitalization.
Health officials stress that any infant showing these symptoms should receive immediate medical evaluation. The diagnosis is primarily clinical, based on the symptom presentation, and treatment should not be delayed while waiting for laboratory confirmation.
The Ongoing Investigation
The investigation is a collaborative effort involving the CDC, the FDA, and multiple state health departments. While epidemiological evidence strongly points to the recalled formula, laboratory testing is ongoing to confirm the presence of Clostridium botulinum.
A significant development occurred when officials from the California Department of Public Health announced that preliminary tests on a can of ByHeart formula fed to a sick infant “suggest the presence” of the type of bacteria that produces the botulism toxin. However, more confirmatory tests are pending, and these results have not yet been officially confirmed at the federal level.
ByHeart, in its statements, has acknowledged the preliminary findings but noted that “more testing is needed” and that the bacteria belongs to a large family, many strains of which are naturally occurring in the environment and do not cause illness. The FDA’s investigation continues to determine the point of contamination and whether any other products are affected.
A Rare Event with a Specialized Treatment
The potential link between powdered infant formula and a botulism outbreak is highly unusual. U.S. News & World Report quoted Dr. Steven Abrams, a nutrition expert at the University of Texas, who said, “This would be extremely rare,” noting that no known outbreaks of infant botulism tied to powdered formula have been previously confirmed.
The specialized treatment, BabyBIG (Botulism Immune Globulin Intravenous), is critical for recovery. This medication, derived from the pooled blood plasma of immunized adults, works by neutralizing the botulinum toxin circulating in the bloodstream. It is produced by the Infant Botulism Treatment and Prevention Program in California, which is the sole source for this life-saving drug worldwide. The CDC has confirmed that all 13 infants in this outbreak received this treatment.
Market Impact and Regulatory Context
Health authorities have been quick to reassure the public that this recall is not expected to create widespread infant formula shortages. The affected product, ByHeart Whole Nutrition Infant Formula, is estimated to account for only about 1% of all infant formula sales in the United States. This stands in stark contrast to the 2022 formula shortage crisis, which was triggered by the closure of a major Abbott Nutrition plant that produced a much larger share of the nation’s supply.
This incident occurs against a backdrop of increased regulatory scrutiny of the infant formula industry. The FDA, under the direction of Health Secretary Robert F. Kennedy Jr., has embarked on “Operation Stork Speed,” a comprehensive review of infant formula ingredients and nutrients, the first such deep examination since 1998. Furthermore, ByHeart itself had a separate recall in 2022 for possible cronobacter contamination and received an FDA warning letter in 2023 detailing “areas that still require corrective actions”.
Clinical Guidance for Healthcare Providers
The CDC has issued specific recommendations for clinicians. Any suspected case of infant botulism should be reported immediately to the state public health department, as it is a notifiable disease. The agency strongly advises that healthcare providers do not wait for laboratory confirmation to begin treatment if clinical symptoms are present.
For case consultation and to secure the BabyBIG antitoxin, clinicians are directed to contact the Infant Botulism Treatment and Prevention Program, which offers 24/7 consultation at 510-231-7600.
Analysis & Next Steps
The ongoing investigation into infant botulism and powdered formula represents a new and concerning frontier for food safety. What is new here is the potential confirmation of a contamination pathway, powdered infant formula, that has no historical precedent. This development matters profoundly because it shifts the understanding of risk for the youngest and most vulnerable population. Unlike known sources such as honey or soil, infant formula is a manufactured product that parents rely upon as a safe, sterile, and complete source of nutrition. A breach in this safety assumption has a deep psychological and practical impact on caregivers nationwide.
The population affected is, first and foremost, infants under one year of age, whose underdeveloped gut microbiomes make them uniquely susceptible to the C. botulinum spores. The burden also falls heavily on their families, who must navigate the fear and uncertainty of a serious illness and the complexities of a product recall. For public health authorities and the infant formula industry, this outbreak is a critical test of surveillance systems, regulatory oversight, and corporate responsibility.
Moving forward, the immediate priority is continued and heightened awareness.
According to attorney Dr. Tony Coveny of nationwide botulism law firm Ron Simon & Associates, “Parents and caregivers must check their formula containers against the recalled lot numbers and remain watchful for symptoms, which can appear weeks after exposure.”
The next steps for regulators and the company are clear: the FDA must complete its investigation with transparency, definitively determining the source of contamination and implementing safeguards to prevent a recurrence. For ByHeart and the broader industry, this event necessitates an urgent, top-to-bottom review of manufacturing and quality control processes to restore the shattered confidence of parents. The long-term work will be to reinforce the safety net that protects infants, ensuring that the very products designed to sustain them do not put them in harm’s way.
