In late 2025, a cluster of infants across the United States began arriving at hospitals with constipation, weak feeding, and sudden loss of head control. All were diagnosed with infant botulism, a rare but serious illness caused by a nerve toxin. Within weeks, federal investigators traced many of the cases to ByHeart Whole Nutrition infant formula, triggering a nationwide recall and an intensive review of how quickly dangerous products are pulled from store shelves.
Clostridium botulinum spores, which can produce botulinum toxin, were found in ByHeart Whole Nutrition infant formula and linked to a growing number of infant illnesses. Investigators later confirmed botulinum type A in multiple unopened cans from five manufacturing lots. The earliest known illness tied to the outbreak dated back to August 9, 2025, but the full scale only emerged as more hospitals and states reported cases.
By December 10, 2025, the CDC had identified 51 infants in 19 states who had been hospitalized with confirmed infant botulism after consuming contaminated ByHeart formula. All affected babies survived, but many required intensive care for symptoms including trouble swallowing, poor muscle tone, and breathing difficulties. On that same date, the Centers for Disease Control and Prevention broadened its case definition to include any infant with botulism who consumed ByHeart formula since the product’s release in March 2022 and identified an additional 10 infant botulism cases dating back to December 2023 that appeared consistent with the outbreak pattern.
Investigators found no evidence that other infant formula brands were involved, focusing attention squarely on ByHeart’s product and production systems.
ByHeart’s Growth and the Recall
ByHeart Inc., founded in 2016 and headquartered in New York, entered the infant formula market in March 2022 with a premium, whole-nutrition product. Its formula was produced at facilities in Iowa, Oregon, and Pennsylvania. Despite holding only about 1% of the U.S. formula market, the brand had built a strong reputation among parents seeking higher-end options.
That trajectory changed in early November 2025. On November 7, the U.S. Food and Drug Administration (FDA) notified ByHeart that 13 confirmed infant botulism cases had been linked to its formula. The company initiated a voluntary recall of two production lots on November 8. As more illnesses surfaced and additional testing detected botulinum toxin, ByHeart expanded the recall on November 11 to cover all of its formula products distributed nationwide.
ByHeart’s co-founder and president, Mia Funt, publicly emphasized that infant safety was the company’s top priority and stated the firm acted quickly once alerted. ByHeart reported testing 36 samples of its product and reported positive results to the FDA on November 19, when five of those samples tested positive for Clostridium botulinum Type A. The company offered free replacement formula to families who had purchased affected batches, but the recall left its brand under intense scrutiny and its future uncertain.
Retailers Slow to Pull Product
Even after the expanded recall, federal inspectors found recalled ByHeart products still available for sale at major retail chains. Some locations continued selling the formula for days after the recall, and in some cases, discounted pricing was reportedly offered on items that should have been removed from shelves.
On December 12, 2025, the FDA issued formal warning letters to Walmart, Target, Kroger, and Albertsons, accusing them of failing to promptly and fully remove recalled ByHeart formula from their stores. Inspectors documented recalled products still on shelves and in inventory systems after the recall dates. As of November 26, federal inspectors confirmed that all ByHeart products had been removed from major retail shelves. Nonetheless, the FDA gave the chains 15 working days to submit detailed corrective action plans or face enforcement measures, including potential seizures or court injunctions.
Albertsons later confirmed it had sold the recalled product in multiple states but stated that ByHeart formula was ultimately pulled from all of its stores.
Federal Investigation and Market Impact
The FDA’s Human Foods Program launched a broad investigation, conducting on-site inspections at ByHeart production facilities as well as at distribution and retail sites. Inspectors reviewed production records and earlier inspection findings from 2022 through 2025 that had already raised questions about contamination controls and sanitation practices. Because infant botulism associated with dairy-based products is extremely rare, pinpointing how Clostridium botulinum spores entered the manufacturing process proved difficult.
At the same time, the CDC and state health departments coordinated testing of unopened formula cans from multiple lots. Between August 1 and November 10, 2025, 84 infants nationwide were treated for botulism of all types. Of those, 36 had been exposed to powdered infant formula. Approximately 40% of the formula-exposed group were linked to ByHeart products, a disproportionate share given the company’s relatively small market footprint.
The large-scale recall rattled a formula market still recovering from the 2022 Abbott Nutrition shutdown and subsequent supply shortages. Parents who had selected ByHeart for its perceived quality now confronted the reality that a premium label did not guarantee safety, intensifying demands for transparency and stronger safeguards across the entire industry.
Policy, Legal, and Future Implications
The ByHeart botulism outbreak drew rapid attention from lawmakers and regulators. Members of Congress began reviewing FDA oversight of infant formula manufacturing and recall enforcement. The FDA’s warning letters to major retailers fueled calls in Washington for tougher penalties on companies that fail to act quickly on recall notices, especially when vulnerable populations such as infants are at risk.
Legal exposure also grew. ByHeart faced potential liability related to the contamination and adequacy of its safety controls, while retailers risked claims from affected families over the continued sale of recalled products after public warnings. Federal officials signaled that additional enforcement steps were possible if companies did not meet the FDA’s recall and corrective action requirements.
As the investigation continued, experts questioned how effectively existing systems track recalled goods through complex supply chains and across thousands of retail points. The outbreak thrust recall technology and traceability tools into the spotlight, with public health agencies and policymakers urging faster, more reliable methods for identifying and removing hazardous food products.
For parents and caregivers, the episode badly damaged trust in an essential product category. Families that had relied on formula marketed as carefully sourced and rigorously tested now pressed manufacturers and retailers alike to demonstrate stronger safety cultures. Public health officials and lawmakers framed the crisis as a turning point for infant nutrition oversight: a reminder that rare but severe hazards can still emerge, and a test of whether the formula industry and regulators will close the gaps exposed by this outbreak before the next one occurs.
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