The Outbreak at a Glance
Federal health officials are investigating a significant multistate outbreak of infant botulism linked to a powdered infant formula. The situation is dynamic, with case counts rising as the investigation progresses.
- Product Identified: The outbreak is linked to ByHeart Whole Nutrition Infant Formula. The company initiated a voluntary recall of all of its infant formula products on November 11, 2025. This includes all unexpired lots of formula cans and single-serve “anywhere pack” sticks.
- Cases and Hospitalizations: As of the most recent update on November 19, 2025, a total of 31 infants across 15 states have been reported with suspected or confirmed infant botulism after consuming the recalled formula. All 31 infants have been hospitalized. No deaths have been reported.
- Infant Demographics: The affected infants range in age from 16 to 200 days. For the 24 infants with sex information available, 11 (46%) are female.
The following table outlines the states where cases have been reported as of November 19, 2025:
| State | ||
| Arizona | Michigan | Rhode Island |
| California | Minnesota | Texas |
| Idaho | North Carolina | Washington |
| Illinois | New Jersey | |
| Kentucky | Oregon | |
| Maine | Pennsylvania | |
Investigation Timeline and Key Findings
The investigation, a collaborative effort between the U.S. Food & Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the California Department of Public Health (CDPH), and the Infant Botulism Treatment and Prevention Program (IBTPP), has evolved rapidly, with critical findings emerging over a matter of days.
The table below summarizes the key developments in the investigation:
| Date | Key Investigation Update |
| November 8, 2025 | Initial recall of two specific lots of ByHeart formula after 13 cases in 10 states were reported. All infants had been fed the formula |
| November 11, 2025 | Recall expanded to all ByHeart infant formula products due to increasing illnesses and a preliminary positive test from an opened can by CDPH |
| November 19, 2025 | ByHeart reports that third-party testing of unopened formula from its facility identified Clostridium botulinum. CDPH confirms the presence of Clostridium botulinum type A in a culture from an opened can linked to a sick infant |
Epidemiological evidence has been a cornerstone of the investigation. Interviews with caregivers conducted by state and local health officials consistently revealed that all 31 identified infants had been fed ByHeart Whole Nutrition powdered infant formula in the month before they became ill. This strong pattern pointed investigators toward the product even before laboratory confirmation was complete.
A particularly telling statistic from the CDC’s investigation highlights the significance of the link: data from the IBTPP showed that since August 1, 2025, 84 infants nationwide had received treatment for infant botulism. Of these, 36 had any exposure to powdered infant formula. Notably, more than 40% (15) of those infants had consumed ByHeart brand formula, despite the brand representing only an estimated 1% of all infant formula sales in the United States. This disproportionate representation strongly indicated a specific problem with this brand.
What Consumers Should Do Immediately
Federal agencies have issued clear and urgent guidance for parents and caregivers.
- Stop Using the Formula Immediately: Do not use any ByHeart Whole Nutrition infant formula. This includes all lots, sizes, and formats (cans and single-serve packets).
- Do Not Dispose of the Container: If you have the recalled powdered formula, take a photo of the information on the bottom of the package for your records. Keep the container in a safe spot and label it “DO NOT USE.” If your child develops symptoms, your state health department may want to collect it for testing. If no symptoms appear after 30 days, you can then throw the container away.
- Clean Thoroughly: Wash and sanitize all items and surfaces that may have touched the recalled formula, such as baby bottles, nipples, and preparation areas, using hot, soapy water or a dishwasher.
- Seek Immediate Medical Care for Symptoms: Contact a healthcare provider right away if your infant has consumed this formula and shows any symptoms of infant botulism.
Understanding Infant Botulism
Infant botulism is a rare but serious illness caused by ingestion of spores of the bacterium Clostridium botulinum. These spores can germinate, grow, and produce a toxin in the infant’s intestines. This neurotoxin attacks the body’s nerves, leading to muscle weakness and paralysis.
It is crucial for parents and healthcare providers to recognize the symptoms, which often appear gradually and can take several weeks to develop after exposure.
- Early Symptoms: Constipation, poor feeding, loss of head control, and difficulty swallowing.
- Progressive Weakness: A weak cry, decreased facial expression, droopy eyelids, and a general loss of muscle tone, making the infant appear “floppy”.
- Severe Complications: If untreated, the paralysis can progress to breathing difficulties and respiratory arrest, requiring mechanical ventilation and lengthy hospitalization.
The specialized treatment for infant botulism is BabyBIG® (Botulism Immune Globulin Intravenous), an antitoxin that works by neutralizing the toxin circulating in the bloodstream. The CDC has confirmed that all 31 infants in this outbreak have been hospitalized and received this treatment.
Ongoing Retail and International Concerns
A significant concern raised by the FDA is that, despite the comprehensive recall, the recalled ByHeart formula has still been found on store shelves in multiple states as recently as November 20, 2025. The affected retailers include multiple Walmart, Target, and Kroger locations, as well as one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations. The FDA is working with state partners and retailers to ensure the immediate removal of these products from stores across the country.
The recall also has an international dimension. Customer information provided by Amazon shows that a limited quantity of the recalled ByHeart infant formula was distributed to over 20 other countries, including Argentina, Brazil, Canada, China, Japan, and the United Kingdom. The FDA advises consumers worldwide not to use any ByHeart brand infant formula, as all products are included in this recall.
The Scientific and Regulatory Response
The detection of Clostridium botulinum in a powdered infant formula is a complex and serious event. The investigation is now focused on determining the precise point of contamination within the supply chain or manufacturing process. Companies producing ready-to-eat foods, including infant formula, are required to implement rigorous food safety plans, known as Hazard Analysis and Critical Control Point (HACCP) systems, to prevent, eliminate, or reduce food safety hazards.
As the FDA’s investigation continues, the agency, along with the CDC, will work to understand how this contamination occurred and what steps can be taken to prevent a similar event in the future. Ongoing testing of both unopened and retained product samples is underway, with results expected in the coming weeks.
Historical Precedents: A Recurring Public Health Challenge
Foodborne illness outbreaks have repeatedly shaped U.S. food safety policies. The 1993 Jack in the Box E. coli outbreak was a pivotal moment, resulting from undercooked beef patties. It caused four child fatalities and hundreds of hospitalizations. The public outrage and tragedy directly led to the modernization of meat industry practices, including the mandatory implementation of Hazard Analysis Critical Control Point (HACCP) inspection systems in processing plants.
Just over a decade later, the 2008-2009 Salmonella outbreak linked to the Peanut Corporation of America (PCA) demonstrated the vast reach of a contaminated ingredient. PCA’s peanut butter and peanut paste, used in hundreds of other products, sickened over 700 people across 46 states and was linked to nine deaths. Investigations revealed the company knowingly shipped contaminated products, leading to one of the largest food recalls in U.S. history and resulting in a 28-year prison sentence for the CEO, the longest ever for a foodborne illness case.
The threat of Listeria in ready-to-eat foods has also caused severe outbreaks. In 1985, soft cheese from Jalisco Products caused a Listeria outbreak that resulted in 52 deaths, including 19 stillbirths and 10 infant deaths, making it the deadliest outbreak tracked by the CDC at the time. More recently, a 2011 Listeria outbreak in cantaloupes from Jensen Farms became one of the deadliest in recent history, causing 33 deaths and one miscarriage across 28 states.
A Precedent for Botulism in Sealed Goods
While infant botulism from formula is unprecedented, botulism from commercially prepared, shelf-stable goods has occurred before. A famous case in 1971 involved a can of Bon Vivant vichyssoise soup, which led to one death and caused the company to file for bankruptcy after a massive recall. These historical cases underscore a constant truth articulated by food safety experts: “…foodborne outbreaks are preventable, but food systems are constantly changing, and some things slip past our prevention measures“.
Analysis & Next Steps
The ongoing infant botulism outbreak represents a serious and evolving public health challenge. What is new and particularly concerning here is the conclusive finding of Clostridium botulinum in unopened containers of powdered infant formula, a product parents rely upon as a sterile and safe source of nutrition for their most vulnerable family members. This development matters because it shifts the understanding of risk for infants, revealing a contamination pathway in a manufactured product that has led to dozens of hospitalizations across the country.
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 remains vigilance. Parents and caregivers must check their homes for any recalled ByHeart formula and stop using it immediately, while remaining watchful for symptoms that 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.
