A hospital room teems with activity as doctors rush to stabilize a baby, struggling to breathe, diagnosed with infant botulism. Just hours earlier, the infant’s caregivers fed them ByHeart Whole Nutrition infant formula. Within weeks, 51 babies in 19 U.S. states were hospitalized with similar symptoms—constipation, poor feeding, and loss of head control.
The outbreak began as early as August 9, 2025, but its national impact only became clear as the cases spread like wildfire. Federal authorities rushed to contain the crisis. What went wrong?
Rare Toxin Emerges
Clostridium botulinum spores, responsible for infant botulism, contaminated ByHeart Whole Nutrition infant formula. The infection took hold nationwide, escalating quickly as the CDC expanded its case definition on December 10, 2025, identifying 10 additional botulism cases dating back to 2023.
By November, 51 confirmed cases across 19 states had hospitalized all affected infants. How could such a rare and deadly toxin slip through?
ByHeart’s Rise
ByHeart Inc., founded in 2016 and based in New York, launched its infant formula in 2022. With its formula manufactured in Iowa, Oregon, and Pennsylvania, ByHeart controlled only 1% of U.S. sales but had begun making waves with parents seeking organic, premium options.
But in August 2025, everything changed. On November 8, California authorities discovered botulinum toxin in a batch of ByHeart formula. Could history repeat itself?
Recall Pressures Mount
The FDA first alerted ByHeart of the botulism outbreak on November 7, 2025, with 13 confirmed cases traced to their formula. The company acted swiftly, recalling two lots the next day. However, the recall expanded on November 11, 2025, to cover all ByHeart formula nationwide after more cases and positive tests.
Retailers were ordered to remove the contaminated product from shelves, but compliance was slow as the outbreak continued to spread.
Retailers Defy Recall
On December 12, 2025, the FDA issued warning letters to Walmart, Target, Kroger, and Albertsons after the stores failed to pull recalled ByHeart products. Even after the expanded recall, stores like Target continued to sell the contaminated formula until November 20, 2025.
Some even offered discounts on the recalled items. The FDA demanded corrective action within 15 days or risked seizures and other legal consequences.
19-State Spread
The outbreak spread across 19 states, with California identifying the botulinum toxin in a ByHeart lot consumed by a sick infant. The infection was most prevalent in regions with high retail presence, but no fatalities were reported.
Even after the recall, inspections revealed recalled products were still on store shelves. The crisis deepened as the investigation continued.
Babies’ Harrowing Symptoms
Infants as young as 16 days old experienced severe symptoms of botulism—loss of head control, trouble swallowing, and difficulty breathing. ByHeart Co-Founder and President Mia Funt reassured parents, calling safety the company’s top priority.
However, caregivers across 19 states reported feeding ByHeart formula before their infants fell ill, spanning from August to November 2025. Parents were left searching for answers to the deadly outbreak.
FDA Cracks Down
FDA’s Human Foods Program launched an investigation, conducting onsite inspections at ByHeart’s production facilities and retail locations. The agency sent warning letters to major chains like Walmart and Target, citing their failure to remove recalled products despite repeated notifications.
The CDC and states tested unopened formula samples, confirming botulinum type A in five lots by November 19, 2025. The formula supply chain was in disarray.
Formula Market Shock
Infant formula recalls are rare but carry a massive impact. ByHeart’s 1% market share made the recall even more significant, shaking confidence in the formula industry. The recall echoed the 2022 Abbott shortage, which exposed vulnerabilities in the market.
By November 26, 2025, all ByHeart products had been removed from shelves—yet problems continued as retailer compliance was lagging.
Outbreak Scope
By November 10, 2025, the FDA reported 84 babies had been treated for botulism since August 1. Among them, 36 infants were exposed to powdered infant formula, with 40% of those cases linked to ByHeart. Despite its small market share, ByHeart had a disproportionate impact on the outbreak, making it the center of investigation.
No other brands were implicated.
Retailers Under Fire
Walmart, Target, and Kroger faced mounting criticism for selling recalled ByHeart formula. Albertsons also confirmed sales of the contaminated product in several states. The FDA’s scrutiny revealed severe lapses in tracking, exposing the challenges of managing widespread recalls across thousands of locations.
Retailers scrambled to defend themselves as the FDA’s enforcement deadline loomed.
ByHeart Leadership Steps Up
ByHeart Co-Founder and President Mia Funt addressed the crisis, stating that the company acted swiftly and transparently. After testing 36 samples, ByHeart found positive results and notified the FDA on November 19, 2025.
While no leadership changes occurred, the company’s commitment to transparency was tested as public trust waned. Retailer failures shifted some of the blame, but the crisis forced ByHeart to adapt.
Removal Efforts Accelerate
Albertsons confirmed that ByHeart products were pulled from its shelves following the recall notices. By November 26, 2025, no recalled stock remained in stores. The FDA’s inspections confirmed this, but corrective action was still required.
ByHeart offered free replacements to families who discarded affected batches, but the recovery was slow.
Experts Question Controls
FDA inspections of ByHeart’s facilities between 2022 and 2025 raised questions about contamination controls. The rarity of botulism in dairy products made the source of contamination hard to pinpoint.
With ongoing tests of unopened cans, some experts expressed skepticism about finding the full root cause. Meanwhile, the FDA’s 15-day deadline for corrective plans intensified the pressure.
Enforcement Looms Ahead
If retailers fail to submit corrective action plans by the December 2025 deadline, the FDA could seize products or seek injunctions. Investigations continue, with results expected soon.
The outbreak has highlighted gaps in recall technology, sparking calls for reforms in infant nutrition safety to prevent future crises.
Policy Scrutiny Intensifies
Congress is now eyeing FDA oversight as the botulism outbreak hits vulnerable infants. The FDA’s warning letters to retailers like Walmart and Target may prompt legislative changes.
Calls for stricter penalties for retailers who fail to act on recalls are gaining momentum in Washington, D.C., as political pressure mounts.
Global Echoes
International reports of ByHeart-related infant illness are minimal, with the U.S. facing the brunt of the recall.
Federal and state authorities continue to handle the outbreak as the investigation proceeds.
Legal Threats Mount
Legal threats loom for ByHeart as failure to comply with the FDA’s deadlines could lead to seizures or lawsuits. Retailers face potential litigation from affected families in 19 states.
The ongoing investigation into the source of contamination may bring additional liability.
Parental Trust Shattered
The ByHeart botulism outbreak has shaken parental trust in infant formula brands. Caregivers who valued premium formulas for their purity now demand greater transparency.
This cultural shift challenges ByHeart to prove its commitment to safety.
Safety Wake-Up Call
This outbreak is a wake-up call for the U.S. formula supply chain. Retail delays intensified the crisis, leaving 51 infants hospitalized.
With testing still underway, the need for faster, more reliable recall mechanisms has never been clearer. Will the industry act to prevent the next crisis?
Sources:
U.S. Food and Drug Administration (FDA) Press Announcement (December 14, 2025) – FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Linked to Infant Formula
Centers for Disease Control and Prevention (CDC) Investigation Notice (Updated December 16, 2025) – Outbreak Investigation of Infant Botulism: Infant Formula
FDA Warning Letter to Walmart Inc. (December 12, 2025) – MARCS-CMS 720400
FDA Warning Letter to Target Corporation (December 12, 2025) – MARCS-CMS 720402
California Department of Public Health (CDPH) News Release (December 17, 2025) – California Alerted CDC of Multistate Infant Botulism Outbreak Linked to Formula
ByHeart Inc. Voluntary Recall Announcement (November 2025) – ByHeart Voluntarily Recalls Whole Nutrition Infant Formula Due to Possible Health Risk