A major infant formula brand has initiated an urgent product recall after dangerous bacteria was detected in its products, leading to multiple infants being hospitalised across the United States.
Recall Details and National Impact
ByHeart, a company based in Reading, Pennsylvania, has issued a voluntary recall for two specific batches of its Whole Nutrition Infant Formula. This action follows a notification from the US Food and Drug Administration (FDA) concerning a wider investigation into a recent outbreak of infant botulism.
The FDA informed ByHeart on November 7 about 83 reported cases of infant botulism across the nation since August 2025. Critically, of these cases, 13 infants had consumed ByHeart formula at some point prior to their hospitalisation. These concerning reports originated from ten different states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
The FDA has been careful to note that no direct causal link has been confirmed between any specific infant formula brand and the illness. However, the California Department of Public Health tested a can of ByHeart powdered infant formula that had been fed to an infant diagnosed with botulism. Their preliminary results indicated the presence of the bacteria capable of producing the botulinum toxin.
Understanding the Health Risks of Infant Botulism
Infant botulism is a rare but serious, and potentially life-threatening, condition that affects babies, typically those under 12 months old. In the United States, approximately 200 to 300 cases are reported annually, with about two-thirds of these being the infant form of the illness.
The condition occurs when spores of the Clostridium botulinum bacterium are ingested and then colonise an infant's intestines. There, they can grow and produce the botulinum toxin, which is one of the most potent natural toxins known to science. It is crucial to understand that in infant botulism, the food itself does not contain the pre-formed toxin; rather, it contains the spores that have the potential to produce the toxin inside the baby's body.
Symptoms parents should be vigilant for include:
- Constipation
- Poor feeding and lethargy
- Drooping eyelids
- A weak cry
- Low muscle tone (the baby may feel 'floppy')
- In severe cases, respiratory difficulty or arrest
The primary treatment involves an antitoxin called Botulism Immune Globulin Intravenous (BIG-IV), administered through a single infusion. Supportive hospital care, which may include breathing support with a ventilator and nutritional support via IV or feeding tubes, is also essential. Fortunately, the death rate is very low, at less than 1%, but recovery can be a long process, sometimes taking months or even years. To date, no deaths have been reported in connection with this specific outbreak.
Company Response and Consumer Action
The voluntary recall applies specifically to two batches of ByHeart Whole Nutrition Infant Formula. The affected products have the batch codes 251261P2 and 251131P2. Both batches share the same use-by date of December 1, 2026, and the UPC code 5004496800.
ByHeart has emphasised that this recall is being conducted 'out of an abundance of caution'. 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.' She added that while no contamination has been confirmed, the voluntary recall reflects the company's commitment to transparency and safety.
Consumers are urged to immediately check the bottom of their ByHeart formula cans for the batch code and use-by date. No other batches are affected by this recall. Parents who have purchased products from the affected batches should stop using the formula immediately and dispose of it. ByHeart has committed to replacing any recalled cans at no cost to consumers.
Parents should contact their healthcare provider without delay if their infant shows any symptoms consistent with botulism.
