All ByHeart Whole Nutrition infant formula products have been recalled after 15 babies across 12 states developed botulism from contaminated batches
A serious outbreak of infant botulism has prompted federal health officials to investigate contaminated baby formula that has sickened 15 infants across 12 states. The Centers for Disease Control and Prevention, working alongside the Food and Drug Administration and state health departments, is examining cases linked to ByHeart Whole Nutrition infant formula products.
All 15 affected babies have required hospitalization, though no deaths have been reported in connection with this outbreak. The investigation remains active as health officials work to determine the full scope of contamination and prevent additional cases from developing.
Company expands recall amid growing concerns
ByHeart Inc. initially issued a limited recall on November 8, 2025, but expanded it to include all ByHeart Whole Nutrition infant formula products just three days later. The decision came after parents and caregivers reported that babies in the outbreak had consumed different lot numbers of the formula that were not included in the original recall.
The expanded recall now covers all lot numbers and sizes of ByHeart Whole Nutrition infant formula, including both canned products and single-serve packets. The formula is widely available through online retailers and major stores nationwide, making the recall particularly significant for families who may have recently purchased the products.
Understanding infant botulism and its symptoms
Infant botulism occurs when babies ingest Clostridium botulinum spores that subsequently grow in their intestinal tract and produce dangerous toxins. Unlike adult botulism, which typically results from consuming pre-formed toxins in contaminated food, infant botulism develops when the spores germinate inside the baby’s digestive system.
The condition often begins with constipation, which may be the first sign parents notice. However, the more concerning symptoms that typically prompt medical attention include difficulty feeding, problems with sucking and swallowing, a noticeably weak or altered cry, and loss of head control. These symptoms reflect the progressive muscle weakness that characterizes botulism.
Immediate action required from parents and caregivers
Health officials are urging all parents and caregivers to immediately stop using any ByHeart Whole Nutrition infant formula products. This includes all varieties, lot numbers, and package sizes, regardless of when they were purchased or whether they appear on recall lists.
Families should record lot numbers and expiration dates if possible before disposing of the products. However, if a baby has already consumed the formula, parents should retain any leftover powder for at least one month in case health officials need to test it. The formula should be stored safely away from children and pets during this period.
Symptoms may take weeks to develop
One of the most concerning aspects of this outbreak is the delayed onset of symptoms. Infant botulism can take several weeks to manifest after exposure, meaning babies who consumed the contaminated formula recently may not show signs of illness immediately. Parents who have used ByHeart formula should remain vigilant and monitor their infants closely during this extended period.
The progressive nature of infant botulism makes early detection crucial. If left untreated, the condition can lead to severe complications including breathing difficulties and prolonged hospitalization lasting weeks or months. The paralysis associated with botulism typically begins in the head and face before spreading to other parts of the body.
Medical professionals mobilize response efforts
Healthcare providers across the country have been alerted to watch for potential cases and begin immediate treatment protocols. The California Department of Public Health Infant Botulism Treatment and Prevention Program is providing 24-hour consultation services for suspected cases, accessible at 510-231-7600.
Medical professionals are being advised not to wait for laboratory confirmation before beginning treatment with BabyBIG®, the recommended therapy for infant botulism. Early intervention can significantly improve outcomes and reduce the duration of illness and hospitalization.
Businesses and retailers respond to recall
Retailers and healthcare facilities are being instructed to immediately remove all ByHeart Whole Nutrition infant formula products from their shelves and inventory. Businesses must also thoroughly clean and sanitize any surfaces or equipment that may have come into contact with the recalled products to prevent cross-contamination.
The widespread availability of ByHeart formula through multiple retail channels means the recall affects numerous businesses across the country. Companies are working to identify and remove affected products while notifying customers who may have recently purchased the formula.
Investigation continues as officials seek answers
Federal and state health officials continue investigating how the contamination occurred and whether additional products may be affected. The investigation involves testing formula samples, examining manufacturing processes, and tracking the distribution of contaminated batches to identify all potentially affected consumers.
This outbreak serves as a reminder of the critical importance of food safety in infant nutrition products, where even small amounts of contamination can have serious health consequences for vulnerable populations.
Story credit: CDC