An urgent recall has been announced by a baby formula manufacturer following the detection of hazardous bacteria in some of its products, which have been linked to several hospitalizations nationwide.

ByHeart, a company headquartered in Reading, Pennsylvania, has proactively recalled two lots of its Whole Nutrition Infant Formula. This decision comes in response to information from the FDA, which is conducting an extensive investigation into a recent outbreak of infant botulism.

The FDA notified ByHeart on November 7 about 83 incidents of infant botulism reported across the country since August 2025. Out of these cases, 13 infants who had reportedly consumed ByHeart’s formula were hospitalized. These instances have been documented in 10 states, including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

While no definitive link between any specific infant formula brand and the illness has been established, the FDA is taking these reports seriously. In particular, the California Department of Public Health conducted tests on a can of ByHeart powdered infant formula that had been given to a child diagnosed with infant botulism. Preliminary findings indicate the presence of bacteria that produce botulinum toxin.

The FDA emphasized that no direct connection has been confirmed between any infant formula brand and the illness. 

However, the California Department of Public Health has tested a can of ByHeart powdered infant formula that was fed to an infant with infant botulism and preliminary results suggest the presence of the bacteria that produce botulinum toxin.

The voluntary recall applies to two batches of ByHeart Whole Nutrition Infant Formula with the batch codes 251261P2 and 251131P2.

Both batches share the same use-by date of December 1, 2026 and UPC 5004496800. 

ByHeart, based in Reading, Pennsylvania, has issued a voluntary recall of two batches of its Whole Nutrition Infant Formula

Infant botulism is a rare but potentially fatal condition that affects babies, usually under 12 months old. 

In the US, there are typically around 200 to 300 cases of infant botulism reported each year. The majority of these, roughly two-thirds, are infant botulism, which usually affects babies under one year old. 

It happens when spores of the bacterium Clostridium botulinum enter an infant’s intestines, where they can grow and produce botulinum toxin – one of the most potent natural toxins known.

Symptoms can include constipation, poor feeding, drooping eyelids, weak cry, low muscle tone, and in severe cases, respiratory difficulty or arrest.

In infant botulism, the food doesn’t contain toxin; it contains spores that have the potential to produce toxin inside the baby’s body.

The best-known food linked to infant botulism is honey. That’s why health authorities advise never giving honey to babies under 12 months.

Occasionally, spores can also be found in dusty home environments, unwashed produce, or powdered foods, though these are much rarer routes of exposure.

The main treatment for infant botulism is an antitoxin called Botulism Immune Globulin Intravenous (Human), or BIG-IV, administered via a single intravenous infusion. 

Supportive care is also essential, which may include hospitalization, breathing support with a ventilator if needed, and IV fluids or tube feedings to maintain nutrition if the infant has difficulty swallowing. 

Early diagnosis and treatment are crucial for a favorable outcome. 

While death is rare at less than 1percent, recovery can be a lengthy process, requiring months or even years for full recovery.

To date, no deaths have been reported from the outbreak.  

The company has highlighted that the recall is being conducted out of an abundance of caution, as the FDA has not established any direct link between infant formula and the reported cases of botulism. 

Consumers can find the batch code and use-by date printed on the bottom of the can. No other batches are affected

There is also no historical precedent of infant formula causing infant botulism.

‘No ByHeart product has tested positive for any contaminants,’ said Mia Funt, Co-Founder and President of ByHeart. 

‘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.’

Funt added that ByHeart follows the highest global and US safety standards and testing protocols for its products. Laboratory confirmation for some cases is ongoing. 

Consumers can find the batch code and use-by date printed on the bottom of the can. No other batches are affected.

Consumers who purchased products from the affected batches have been advised to immediately discontinue use and dispose of the formula. ByHeart will replace any recalled cans at no cost.

Parents should contact their healthcare provider if their infant shows symptoms consistent with botulism.