Lead
On November 8–9, 2025, ByHeart Inc. agreed to recall some of its powdered infant formula after 13 infants were diagnosed with botulism following consumption of the product. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have opened an investigation into the cluster, which includes hospitalizations reported across 10 U.S. states. All confirmed cases involve infants who consumed ByHeart branded powdered formula. Health authorities and the manufacturer say a recall is intended to limit further risk while officials seek the source of contamination.
Key Takeaways
- ByHeart has agreed to a voluntary recall of some powdered infant formula after 13 infants were diagnosed with botulism on Nov. 8–9, 2025.
- CDC and FDA have launched a joint investigation; hospitalizations related to the cases were reported across 10 states.
- All confirmed patients consumed ByHeart brand powdered infant formula, though specific lot numbers have not yet been publicly detailed.
- Infant botulism is caused by Clostridium botulinum spores; infants are especially vulnerable to intestinal colonization and neurotoxin effects.
- Public health guidance emphasizes stopping use of the implicated product until regulators and the company provide lot-level instructions.
- The recall may trigger temporary supply and distribution disruptions for formula segments serving infants with specialized nutrition needs.
- Authorities are tracing production, distribution and household handling to determine when and how contamination occurred.
Background
Infant botulism is an uncommon but serious illness caused by ingestion of Clostridium botulinum spores, which then germinate and produce neurotoxin in the infant gut. Typical early symptoms include constipation, poor feeding, lethargy and weak cry; untreated cases can progress to respiratory failure, often necessitating hospitalization. Historically, honey has been a recognized source of spores for infants, and powdered foods have occasionally been scrutinized when clusters emerge.
The U.S. infant formula industry is heavily regulated, with manufacturing, testing and distribution controls intended to limit contamination risk. Still, powdered formula is not sterile by definition, and manufacturers follow strict sanitation and supply-chain checks. When regulators detect a possible link between product and illness, they combine epidemiologic interviews, laboratory testing and trace-back investigations to identify a contaminated lot, production step or ingredient.
Main Event
On November 8, 2025, public reports identified a cluster of 13 infant botulism cases connected to consumption of ByHeart powdered formula; the story was updated on Nov. 9 as the recall was announced. ByHeart notified regulators and agreed to remove some powdered product from the market while investigators conduct testing and trace-back work. The company characterized the action as precautionary pending results.
CDC and FDA teams are interviewing families, collecting product samples from homes and retail outlets, and working with ByHeart to trace distribution paths. According to public reports, hospitalizations have occurred across 10 states, though authorities have not released a state-by-state breakdown or ages of affected infants. Clinical teams are treating cases according to standard protocols for suspected botulism, which can include administration of botulism antitoxin where indicated and supportive respiratory care.
Regulators are focusing on whether contamination originated at a manufacturing site, during transport, in a specific ingredient, or post-purchase handling. Because powdered formula is not sterile, investigations typically compare product lots from affected households to unaffected lots and inspect factory environmental samples for C. botulinum spores.
Analysis & Implications
Public-health impact: A cluster of 13 confirmed infant botulism cases is significant for a rare disease and will prompt heightened surveillance in neonatal care and pediatric clinics. The immediate priority for authorities is to stop further exposures and identify the contamination vector; clear, timely guidance to caregivers will shape short-term risk mitigation.
Regulatory and industry consequences: If officials identify a manufacturing or supply-chain failure, ByHeart may face expanded recalls, regulatory enforcement actions, and requirements for intensified environmental monitoring. The FDA has authority to require corrective actions; the scope of any formal enforcement will depend on what trace-back and laboratory testing reveal.
Market and supply effects: A recall of powdered formula—even if limited to particular lots—can strain supplies for infants who rely on specialized formulas. Retailers and hospitals often keep buffer stocks, but parents of infants with allergies or medical needs could face substitution challenges. This episode may spur contingency planning by pediatric providers and public-health agencies to ensure feeding options for affected infants.
Longer-term trust and consumer behavior: High-profile contamination events tend to sharpen scrutiny of manufacturing practices and can accelerate demand for alternative products (e.g., ready-to-feed formulas) perceived as lower risk. Policymakers may consider whether current production standards and surveillance of powdered infant formula require strengthening to reduce future outbreaks.
Comparison & Data
| Metric | Value |
|---|---|
| Confirmed infant botulism cases | 13 |
| States reporting hospitalizations | 10 |
| Product | ByHeart powdered infant formula (some lots) |
| Investigation | CDC and FDA (joint) |
| Initial report dates | Nov 8–9, 2025 |
The table summarizes the confirmed counts and known investigative actors as of the Nov. 9, 2025 update. Detailed breakdowns by state, affected lot numbers, ages of infants and hospitalization status remain pending public release. Those data points will determine the scale of any expanded recall and regulatory response.
Reactions & Quotes
“We are cooperating with federal investigators and have initiated a recall of affected powdered formula as a precautionary step,”
ByHeart (company statement)
ByHeart’s public statement framed the recall as voluntary and precautionary while investigations proceed. The company indicated it is working with distributors and retailers to remove implicated units.
“Parents should stop using the identified product and consult a clinician if infants show symptoms consistent with botulism,”
CDC (public guidance)
CDC guidance to clinicians and caregivers typically emphasizes early recognition of symptoms and rapid referral for evaluation. The agency and the FDA will update recommendations as lot-level information becomes available.
Unconfirmed
- Specific lot numbers, production dates and manufacturing sites linked to the illnesses have not been publicly detailed by regulators or the company.
- Whether contamination occurred during manufacturing, through an ingredient, or via post-sale handling in homes or distribution channels remains unresolved.
- Detailed clinical status of each infant, including which cases required antitoxin or mechanical ventilation, has not been released publicly.
Bottom Line
The ByHeart recall and the cluster of 13 infant botulism cases reported on Nov. 8–9, 2025, represent a meaningful public-health event for a rare pediatric infection. Immediate efforts by CDC, FDA and the manufacturer are focused on removing potentially implicated product from circulation and determining the contamination pathway.
Parents and caregivers of infants who used ByHeart powdered formula should check communications from the company and regulators for lot-level guidance, discontinue use of any identified product, and seek medical attention if an infant develops symptoms such as constipation, poor feeding, lethargy or weak cry. The coming days of laboratory testing and trace-back work will determine whether the recall expands and what regulatory steps follow.