What to know about ByHeart baby formula linked to potentially fatal infant botulism

An outbreak of infant botulism linked to contaminated baby formula has sickened at least 15 babies nationwide, with laboratory tests ongoing for many other cases, including a child from Nassau County who remains hospitalized with the potentially fatal bacteria-borne illness, federal and local officials said.

The outbreak prompted Manhattan-based ByHeart to recall all its formula, including cans and single-serving sticks — a move that came only three days after the company recalled two of its batches following several reported cases.

Here’s what you need to know about the outbreak and infant botulism:

What is infant botulism and how serious is it?

Infant botulism occurs when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin, according to the Centers for Disease Control and Prevention.

The illness typically begins with constipation but is often first noticed as difficulty feeding or swallowing, a weak and altered cry and loss of head control. It can eventually progress to difficulty breathing and respiratory arrest, officials said.

Symptoms can take several weeks to develop after ingesting formula.

"It's a progression of symptoms," said Dr. David Fagan, vice chairman of pediatric ambulatory administration at Cohen Children's Medical Center in Queens. "But what can then happen is you can get decreased respiratory effort so ... that can affect breathing. And that's where it can get serious. And then sometimes infants have to be put on a ventilator."

Infant botulism typically affects children younger than 1, as their gastrointestinal tract cannot yet kill the spores produced by the Clostridium botulinum bacteria, health officials said.

When did the outbreak begin and how far has it spread?

Since Aug. 1, 84 babies nationwide have received treatment for infant botulism, according to the Infant Botulism Treatment and Prevention Program.

To date, at least 15 babies in 12 states have been hospitalized with confirmed cases of infant botulism tied to formula from ByHeart, according to the U.S. Food and Drug Administration. The babies range in age from 16 to 157 days.

Investigations of the other cases are ongoing but officials have not identified any other infant formula brands or shared exposures that pose a risk to infants.

No deaths have been reported in the outbreak.

"We are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation," Mia Funt and Ron Belldegrun, co-founders of ByHeart, wrote on the company's website this week announcing a voluntarily recall of all its formula nationwide.

What do we know about the Nassau County infant believed to be sickened with infant botulism?

Few details of the case are publicly available, but the Nassau Health Department confirmed that an infant under 1 year of age consumed ByHeart formula and is hospitalized in stable condition.

Lab results linking the infant botulism case to ByHeart formula have not been publicly released and details about where the child lives, or when the baby became ill, were not available.

No other cases have been confirmed in New York State.

"Over the years, we've had many children or infants with infant botulism, often from contaminated spores, food and unpasteurized formulas," said Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children's Hospital. "This outbreak is quite worrisome because it's associated with a formula. And that means the formula company has to do a deep dive to understand, at what point did the formula get contaminated?"

What should parents do if they own ByHeart formula?

Parents should immediately stop feeding their infants ByHeart formula, according to FDA guidance.

If your child consumed the formula and is not showing symptoms, health officials recommend to continue monitoring them and seek medical attention if symptoms develop.

Long Islanders that still have the formula in their home should photograph or note the lot number and expiration date on any ByHeart package; label it as not for use and store it in a secure spot for 30 days.

If the child does not get sick, health officials said it's safe to throw the containers out after 30 days.

Newsday's Nicholas Grasso contributed to this story.

By Robert Brodsky

robert.brodsky@newsday.com@BrodskyRobert

Robert Brodsky is a breaking news reporter who has worked at Newsday since 2011. He is a Queens College and American University alum.