Organic Baby Formula Recalled Over Infant Botulism Outbreak Across 10 States
For many parents, mixing a bottle is a moment of comfort. But across the U.S., that routine has taken a harrowing turn. A major baby formula recall is underway after multiple infants were hospitalized with botulism—an illness so rare that most pediatricians never expect to see a case in their careers.
The First Signs of Trouble
The earliest warnings emerged in late summer when doctors in several states began reporting babies with constipation, weak cries, and drooping eyelids—classic symptoms of botulism. By October, the CDC had linked several cases to ByHeart’s Whole Nutrition Infant Formula, one of the few organic brands marketed as “clean-label.” Hospitals quickly alerted health departments, and an investigation began.
From Caution to Crisis
Initially, ByHeart recalled two lots as a voluntary measure, saying tests were “inconclusive but concerning.” Within weeks, federal investigators detected Clostridium botulinum in an opened can from a confirmed patient’s home. That finding triggered a sweeping recall of all unexpired ByHeart formula sold nationwide, both online and in stores.
Inside the Investigation
The FDA, CDC, and California Department of Public Health traced the contamination back to a single U.S. manufacturing facility. Early evidence suggested that sterilization or packaging processes may have failed during a brief production window.
The recall covers ByHeart Whole Nutrition Infant Formula, specifically lots 206VABP/251261P2 and 206VABP/251131P2 with December 1, 2025 “use by” dates, and has since expanded to all unexpired cans and single-serve “anywhere” sticks sold online and in stores nationwide.
Officials continue to test product samples and inspect distribution centers to determine whether contamination occurred before or after packaging.
How the Company Responded
In a press release via their website, ByHeart CEO Ron Belldegrun said the company was cooperating fully with federal authorities and pausing all production because “[your] baby’s safety is, and always will be, [their] biggest priority”. He emphasized that infant botulism from formula is unprecedented in U.S. history but urged families to immediately discard affected products.
States on Alert
By November 11, confirmed cases had spread to 10 states, including California, Arizona, Texas, Illinois, Pennsylvania, and New Jersey. 15 infants were hospitalized, all of whom required specialized antitoxin treatment known as BabyBIG. While all patients are expected to recover, the outbreak marks the largest infant botulism cluster in U.S. history linked to a commercial product.
What Parents Need to Know
Health officials are urging caregivers to watch for early warning signs such as constipation, lethargy, or feeding difficulties that may appear days or even weeks after exposure. Parents are also asked to photograph and preserve any ByHeart packaging for laboratory testing. The CDC stresses that unopened formula should not be consumed, even if it looks and smells normal.
Why Botulism Is So Dangerous
Infant botulism occurs when spores of Clostridium botulinum colonize a baby’s immature gut, releasing toxins that can cause paralysis. It’s rare, typically under 100 cases annually, but can become life-threatening without treatment. Because powdered formula is not sterile, experts warn that even small lapses in temperature or sealing during production can have devastating consequences.
The Aftermath for the Formula Industry
ByHeart’s recall is the latest blow to a market still recovering from supply chain disruptions and earlier safety scandals. Regulators say the case underscores the need for stricter contamination protocols and transparency in infant nutrition. As the investigation continues, the FDA has vowed to “re-examine powdered formula safety standards across all U.S. manufacturers”.
Moving Forward
Though ByHeart accounts for less than 1% of the national formula market, its recall has reignited anxiety among parents already wary of shortages. Federal agencies expect test results and a full traceability report in the coming weeks. Until then, health officials have one message for families: when it comes to infant safety, it’s better to throw out a can than risk a life.
