Health experts are raising concerns over a rising number of infant hospitalizations in the United States, which have been linked to contaminated baby formula.

ByHeart, a company based in Reading, Pennsylvania, has initiated a nationwide recall of its infant formula products. This decision follows a notification from the U.S. Food and Drug Administration (FDA) concerning a broader investigation into a recent outbreak of infant botulism. This rare condition occurs when bacteria in a baby’s digestive system produce a toxin leading to muscle weakness.

The California Department of Public Health conducted tests on a can of ByHeart powdered formula, consumed by an infant who subsequently developed botulism. Preliminary findings indicated the presence of bacteria responsible for producing botulinum toxin, the agent that causes botulism, in the formula.

The FDA alerted ByHeart on November 7 about reported cases of infant botulism across the country, with the first instances surfacing in August.

Since the last update on November 20, six additional cases have been added to the ongoing investigation, increasing the total number of infants suspected to have been affected by ByHeart formula to 37. Experts warn that the number could continue to rise.

The affected families are being represented by Marler Clark, The Food Safety Law Firm, in collaboration with regional co-counsel.

Lead attorney Bill Marler told the Daily Mail he has now been retained ‘by over a dozen families whose kids are part of this outbreak,’ adding that he expects more cases to surface.

Botulism is especially dangerous for infants because the toxin can paralyze the muscles needed for breathing, leading to respiratory failure. 

To date, 15 infants have been hospitalized after reportedly consuming ByHeart formula (stock image)

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

Laboratory confirmation for some cases is ongoing but for 36 cases with information available, the illnesses started on dates ranging from August 9 through November 19. To date, there have been no deaths reported. 

The cases have been reported in 17 states: Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin.

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. 

But in the meantime, the agency has issued a ‘do not use’ warning for all ByHeart infant formula products.

The voluntary recall applies to all lot numbers and all sizes of cans and single serve packets of ByHeart infant formula.

The CDC advises anyone in possession of the recalled formula to record the lot number and ‘best by’ date if possible. 

Consumers who still have leftover powdered formula that their infant was fed should store it safely for at least one month, rather than discarding it immediately.

According to the agency, this precaution allows time for health officials to collect samples if an infant develops symptoms consistent with infant botulism, such as poor feeding, constipation, or muscle weakness. 

If no symptoms occur after a month, the leftover formula should be discarded.

Parents are also urged to clean and disinfect any items or surfaces that came into contact with the recalled formula using hot, soapy water or a dishwasher to reduce the risk of contamination.

The CDC emphasized that these measures are part of a broader effort to support the FDA’s ongoing investigation and protect infant health while the source of the outbreak is being examined.

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

ByHeart, a manufacturer of organic baby formula that is being recalled, is displayed outside a building that houses a plant for the company

This map shows where the 37 infants in this infant botulism outbreak lived 

The best-known food linked to infant botulism is honey, and health authorities advise never giving honey to babies under 12 months because this is when they are most vulnerable.

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 specifially 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 in botulism not because the toxin spreads to or damages organs directly, but because the toxin blocks the nerves required for essential body functions, especially breathing, and causes progressive paralysis.

While death is rare at less than one percent, recovery can be a lengthy process, requiring months or even years. This is because the toxin permanently disables affected nerve endings. 

Once a nerve terminal is blocked, it cannot be repaired and this means the body must grow entirely new nerve terminals, which is a slow biological process.

For 35 infants with age and sex information available in the current infant botulism outbreak, they range in age from 16 to eight months and 20 days, and 15 (43 percent) are female.

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 

There is 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 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. 

Meanwhile, businesses have been instructed to stop selling the recalled ByHeart Whole Nutrition infant formula and to sanitize any surfaces that may have touched the product.