A major baby formula brand has taken the drastic step of recalling all of its products nationwide following a federal investigation into a dangerous bacterial outbreak that has left multiple children in hospital.
Nationwide Health Alert for Parents
ByHeart, based in Reading, Pennsylvania, announced the voluntary recall after being notified by the US Food and Drug Administration about a concerning spike in infant botulism cases. The FDA informed the company on November 7 about 83 reported cases since August 2025, with the number since rising to 84 confirmed cases across the United States.
The situation has become particularly alarming as health authorities confirmed that 15 infants have been hospitalised after reportedly consuming ByHeart formula. These cases have emerged across 12 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Kentucky, North Carolina, Texas, and Washington.
Investigation and Testing Underway
While the FDA emphasised that no direct connection has been confirmed between any infant formula brand and the illness, officials expressed serious concern. The California Department of Public Health has already tested a can of ByHeart powdered infant formula that was fed to an infant diagnosed with botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, one of the most potent natural toxins known to science.
The recall now applies to all lot numbers and all sizes of cans and single-serve packets of ByHeart infant formula. This expansion reflects the company's "abundance of caution" approach, despite no confirmed product contamination.
What Parents Need to Know
The Centers for Disease Control and Prevention has issued specific guidance for families who may have purchased the affected products. Rather than immediately discarding leftover powdered formula, consumers should store it safely for at least one month. This precaution allows health officials to collect samples if an infant develops symptoms consistent with infant botulism.
Symptoms parents should watch for include:
- Poor feeding or difficulty swallowing
- Constipation
- Muscle weakness or low muscle tone
- Drooping eyelids
- Weak cry
- Respiratory difficulties
Parents are also urged to thoroughly clean and disinfect any items or surfaces that came into contact with the recalled formula using hot, soapy water or a dishwasher to reduce contamination risks.
Infant botulism remains a rare but potentially fatal condition that typically affects babies under 12 months old. In the United States, there are usually between 200 to 300 cases reported annually, with about two-thirds being infant botulism. The condition occurs when spores of the bacterium Clostridium botulinum enter an infant's intestines, where they can grow and produce dangerous toxins.
Mia Funt, Co-Founder and President of ByHeart, stated: "No ByHeart product has tested positive for any contaminants. The safety and well-being of every infant who uses our formula is our absolute highest priority. While there has been no confirmation of contamination, this voluntary recall reflects our deep commitment to transparency and safety for babies and their parents."
The company has committed to replacing any recalled cans at no cost, and no deaths have been reported in connection with this outbreak. Parents whose infants show any concerning symptoms should contact their healthcare provider immediately.
