Health officials say a growing number of infants across the United States have been hospitalized after being exposed to contaminated baby formula. As of early December, that number had climbed to 51, spreading across nearly twenty states.
The situation traces back to an investigation that started months earlier, when several infant illnesses raised red flags. By late summer, concerns centered on possible botulism exposure tied to a specific organic formula product.
In November, the company behind that formula, ByHeart, was instructed by federal regulators to issue a recall. The recall applied to all sizes of its Whole Nutrition Infant Formula, including both cans and single serve packets.
At the time, the company said: “The safety and well-being of every infant who uses our formula is, and always will be, our highest priority.” The statement came as regulators continued reviewing illness reports involving infants.
Testing later confirmed that clostridium botulinum had been found in some formula samples. Officials said this bacterium is known to cause botulism, a serious condition that can be especially dangerous for babies.
The recall effort expanded beyond the manufacturer after inspections showed problems at the retail level. Several major stores, including Walmart and Target, were warned after recalled products were found still sitting on shelves weeks after the recall began.
Federal officials said the situation raised concerns about how effectively recalls were being handled. In a statement, the FDA said: “Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, [the bacteria that causes botulism] which is causing infant illness in multiple regions of the country.”
Health authorities explained that when infants swallow clostridium botulinum spores, the bacteria can grow inside the gut and release toxins. These toxins interfere with normal muscle movement and nerve function.
Early warning signs in babies may include constipation, trouble feeding, changes in crying, reduced facial movement, and difficulty holding up the head. Doctors say symptoms can worsen quickly without treatment.
Officials also warned that severe cases may lead to paralysis and breathing problems. Some infants may require extended hospital stays, sometimes lasting several weeks.
By December 10, hospitalizations had been reported in 19 states, including Arizona, California, Texas, New Jersey, Pennsylvania, and Washington, among others. Despite the growing number of cases, no deaths have been linked to the outbreak so far.
In a recent update shared with a news outlet, ByHeart said it was aware of the expanded review by health officials. The company said it continues working with both federal and state agencies.
They added: “This is an ongoing investigation and we remain committed to transparency and cooperating with federal and state agencies.”
