Multistate Outbreak of Infant Botulism Under Investigation: 13 Infants from 10 States Linked to Infant Formula

Multistate Outbreak of Infant Botulism Under Investigation: 13 Infants from 10 States Linked to Infant Formula

In collaboration with the U.S. Food & Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the California Department of Public Health (CDPH) Infant Botulism Treatment & Prevention Program (IBTPP), and state and local partners, officials are investigating a multistate outbreak of infant botulism linked to powdered infant formula. As of November 8, 2025, 13 infants with suspected or confirmed infant botulism from 10 states have been identified.

What We Know So Far

Public health agencies have issued joint alerts indicating that all 13 identified infants consumed the powdered infant formula brand ByHeart Whole Nutrition prior to onset of illness. On November 11, 2025 the FDA noted, “A total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula … have been reported from 12 states.”

The list of states implicated for an earlier 10‐state figure of infant botulism cases includes Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington (msdh.ms.gov). Distribution and sale of the formula occurred online and at major U.S. retailers. The company’s initial recall involved two lots: Lot 206VABP/251261P2 and Lot 206VABP/251131P2 (“Use by 01 Dec 2026”). 

All infants were hospitalized and treated with the antitoxin BabyBIG®; no deaths have been publicly confirmed to date. Illness onset dates range from August 9 to November 10, 2025. 

What Is Infant Botulism?

Infant botulism occurs when an infant (typically under one year of age) ingests spores of Clostridium botulinum (or related species) which then germinate in the immature gut, produce neurotoxin, and cause neuromuscular paralysis. The disease differs from classic foodborne botulism in that the organism’s toxin is generated within the colon rather than being ingested preformed. CDPH explains, “Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria … which leads to progressive muscle weakness including trouble breathing if not treated in time (CDPH). 

Typical clinical signs begin with constipation and poor feeding and progress to weak cry, decreased facial expression, loss of head control, hypotonia (floppiness), difficulty swallowing, and may progress to respiratory failure if untreated. Treatment relies on early recognition, prompt administration of BabyBIG® (botulism immune globulin intravenous) and supportive intensive care including ventilation in severe cases.

Infant botulism is reportable and rare in the U.S. Historically fewer than 100 cases are reported annually, most without a clearly identified common food source. The current outbreak is unusual for the number and common exposure. 

Why Powdered Infant Formula Might Be Implicated

Infant formula is a low-moisture product, typically considered safer than some other foods from a pathogen perspective, but it is not immune from contamination. The epidemiologic link in this outbreak is strong: all identified cases consumed ByHeart brand powdered formula, and preliminary testing by CDPH found C. botulinum spores in a can of the formula.

Possible contamination pathways include spores present in raw materials (vegetable or milk derivatives), contamination during manufacturing, inadequate kill step (thermal or pressure processing), or contamination of ingredients post-process in the facility. Because infant gut environments allow spore germination more readily than older child/adult guts, infants who ingest spores in formula are at risk even if the formula appears visually and sensorially normal.

Clinical and Public Health Response and Case Management

Because infant botulism progresses rapidly and results in prolonged hospitalization unless treated early, public‐health partners emphasise immediate action. Clinicians suspecting infant botulism should not wait for laboratory confirmation before consulting the IBTPP (phone 510-231-7600 in California) and arranging BabyBIG® therapy. 

Public health departments are interviewing caregivers, collecting leftover formula cans for testing, and tracing distribution of implicated lots. These actions aim to identify the point of contamination, determine whether other lots or brands are affected, and prevent further cases. State labs (e.g., CDPH CLS MDL) are conducting toxin and spore testing; results will inform whether contamination was finished‐product, ingredient, or facility‐based.

Healthcare facilities are advised to monitor for infants presenting with constipation, poor feeding, difficult swallowing, diminished facial expression or floppiness, especially when formula exposure is documented. Early ventilation support and nutritional management are part of care.

Consumer Guidance for Parents and Caregivers

Parents and caregivers of infants who have consumed ByHeart Whole Nutrition powdered formula should act immediately:

1. Stop using the formula if it is of the implicated lot(s), or if uncertain.
2. Retain product packaging (lot number, expiry date) if possible, because public-health officials may request residual samples.
3. Watch for symptoms of infant botulism, even if the infant appears fine now. Symptoms may appear days or even weeks after exposure.
4. Seek medical attention promptly if any signs appear (poor feeding, weak cry, loss of head control, difficulty swallowing, floppiness).
5. Sanitize surfaces and feeding equipment if formula was spilled or prepared in home kitchen, using dishwasher or hot soapy water.

Since infants are uniquely susceptible to colonisation by C. botulinum spores, caregivers should never give honey or home-prepared solids to infants under one year of age (though that is not implicated in this outbreak, it remains standard prevention guidance).

Regulatory and Industry Implications 

This outbreak is notable because infant botulism typically occurs sporadically and rarely with a single food source. The strong signal linking a specific formula brand challenges assumptions that low-moisture powdered foods cannot carry infant botulinum risk. Manufacturers of powdered infant formula must reassess raw‐material sourcing, microbial testing, spore control, facility sanitation, and storage/distribution controls. Regulatory agencies may increase scrutiny of powdered formula manufacturing and encourage enhanced environmental monitoring.

The FDA and CDC are working with the manufacturer to expand recall scope if needed and to identify additional impacted lots or products. They also are evaluating whether the contamination source is formula, water, packaging or facility based. Because infant formula is essential to infants who are not breastfed, regulators must balance risk mitigation with supply continuity; however, industry share of ~1 % for this brand means no broad shortage is anticipated so far. 

State health agencies are issuing health advisories to clinicians, formula retailers and caregivers. The CDPH IBTPP is leveraging its 24/7 consultation service to assist clinicians treating suspected cases nationwide. 

Why the Outbreak Matters and What Makes It Different

1. High severity of illness: All infants were hospitalized. Infant botulism can lead to prolonged ICU stays, ventilation and long-term complications if untreated.
2. Common exposure: A single formula brand across numerous states creates a pattern consistent with a point-source outbreak rather than isolated sporadic cases.
3. Low volume brand, high impact: The implicated brand represents ~1% of formula sales yet appears in a large proportion of formula‐associated cases; this disproportionate representation signals a strong association.
4. Infectious mechanism unique to infants: The immature gut of infants under six months supports spore germination; ingestion of spores (versus pre-formed toxin) is the key risk. The incubation window (days to weeks) complicates recognition and linkage of cases.
5. Manufacturing and supply‐chain implications: Powdered infant formula is widely distributed, often stored in homes and re-packaged in institutions. A contamination event has national reach and public‐trust implications.

Broader Prevention Considerations For Infant Foods 

• Spore-forming bacteria: C. botulinum spores persist in environment and raw materials; infant formula manufacturers must consider spore reduction and in‐process controls, not just pathogen kill steps for vegetative bacteria.
• Environmental monitoring: Facilities producing infant formula must monitor for spore‐forming organisms in clean and manufacturing zones, ensure proper sanitation of equipment, air, water and packaging.
• Traceability and lot‐control: Rapid linkage of infant illness to formula lots requires detailed lot tracking, data sharing across states and coordination among agencies, manufacturers and distributors.
• Consumer education: Caregivers must recognise early signs of infant botulism, understand the importance of storing and preparing formula in accordance with manufacturer instructions, and report unusual symptoms promptly.
• Surveillance and antimicrobial stewardship: Cases must be reported immediately to state health departments; treatment with BabyBIG® is time-sensitive and requires coordination through programs like IBTPP. 

What Comes Next For the Investigation

• Expanded product testing: FDA, CDC and state labs will test unopened and opened containers of the implicated formula brand from different lot codes, shipping distribution data and leftovers from affected infants.
• Traceback of manufacturing steps: The manufacturer’s supply chain, from raw materials through packaging to distribution, is under review to identify where contamination entered.
• Evaluation of facility controls: The formula production facility will undergo review of hazard analysis and critical control points (HACCP), spore-control measures, cleaning procedures, personnel hygiene and equipment maintenance records.
• Potential recall expansion: If other lot numbers or product lines are found contaminated or epidemiologically implicated, recall scope may broaden beyond the initial two lots.
• Clinical case follow-up: Long-term outcomes of the infants will be monitored, and surveillance will check for additional cases beyond the identified 13-15.
• Policy implications: Agencies may revise guidance for powdered infant formula manufacturing, include stricter spore-control requirements and improve environmental monitoring regulation.

Analysis & Next Steps 

What’s New: A multistate outbreak of infant botulism has been detected, with 13 infants across 10 states (now expanded to 15 infants across 12 states) linked to consumption of ByHeart Whole Nutrition powdered infant formula. Environmental and product testing suggests contamination with C. botulinum spores in the formula.

Why It Matters: Infant botulism is rare but dangerous, infants may suffer serious complications or death if treatment is delayed. The strong association with a single brand of formula challenges assumptions about low-moisture food safety for infants and has national-scale implications for formula manufacturing oversight, regulatory policy and consumer trust.

Who’s Affected: Infants (typically less than 6 months old) who consumed the implicated formula; parents and caregivers; pediatricians, hospitals and intensive care units; formula manufacturers and distributors; regulatory agencies; and retailers of infant nutrition products.

What To Do Now:

• Caregivers/consumers: Discontinue use of the implicated formula brand and lot, save packaging with lot codes, monitor infants for early signs of botulism, and seek medical attention immediately if symptoms appear.
• Clinicians: Maintain high index of suspicion for infant botulism in any infant with feeding difficulties, constipation, hypotonia; contact IBTPP immediately (24/7) and administer BabyBIG® without waiting for lab confirmation.
• Manufacturers and retailers: Audit product inventory for the implicated brand and lots, cooperate with recalls, review supply-chain and manufacturing controls for spore contamination risk, and reinforce real-time traceability and environmental monitoring programs.
• Regulators: Accelerate testing and traceback, ensure no other formula brands are implicated, expand recall scope if necessary, and review powdered infant-formula safety standards and guidance for spore-forming pathogens.

Final Note

According to the national food poisoning lawyer, Ron Simon, “This infant botulism outbreak underscores that even foods considered “low-moisture” or packaged for infants cannot be assumed free of contamination risk. The numbers may still be small, but the severity, the national reach, and the vulnerable population (infants) raise the stakes tremendously. Rapid recognition, transparent public communication, coordinated recall action, and rigorous manufacturing and supply-chain controls are all essential to protect infants and preserve trust in infant-nutrition systems.” The identified cases offer a critical opportunity for regulatory review, industry improvement, and clinical preparedness so that future infant feeding remains as safe as possible.