ByHeart, the company linked to an outbreak of botulism from infant formula, said late Wednesday that a private lab had found the bacteria that causes the illness in samples of its product.
So far, 31 babies in 15 states have been hospitalized, many in intensive care units, after becoming weak and unable to swallow. No deaths have been reported.
ByHeart said in a statement that it sent its formula to an independent testing lab on Nov. 7, as soon that the Food and Drug Administration notified the company about the outbreak.
“We have just learned that those tests identified Clostridium botulinum in some samples of ByHeart formula,” the company said, referring to the formal name for the bacteria that cause botulism. “We immediately notified the F.D.A. of those findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again.”
The company has recalled all lots of its formula, and federal officials have warned people not to use any of ByHeart’s infant formula. But state food inspectors reporting to the F.D.A. found some cans of the formula on store shelves in recent days, the agency said.
ByHeart, a newcomer that has sold its formula for only three years, has capitalized on the Trump administration’s Make America Healthy Again movement by promoting its product as an organic, nature-based formula. It has just a tiny share of the formula market, about 1 percent.
The New York Times reported last week that F.D.A. inspection records showed that the company had had manufacturing problems at a Pennsylvania plant, although the company said that plant did not produce the formula linked to the botulism outbreak. ByHeart shut down the facility early this year for improvements after inspectors cited safety and health violations, including thousands of dead bugs in a production area and mold in a clean-water holding tank.
Families of children who became ill have described harrowing experiences in the days before the outbreak was known. Infants grew so weak that their parents rushed them to emergency rooms, where some doctors voiced suspicions that the babies’ symptoms might be caused by frightening, lifelong diseases.
For Tony Barbera and Thalia Flores, the first signs of a problem emerged on a Thursday in October, 26 days after their son, Alessandro, was born. He took to the bottle right away and would drink three ounces of ByHeart formula every three hours “on the dot,” his father said. Soon, though, he was barely ingesting anything.
The baby was unable to close his mouth around the nipple of the bottle. His cry became weak. “It was just a prolonged, soft moan,” Mr. Barbera said.
By Saturday morning, the family’s pediatrician urged Mr. Barbera and Ms. Flores to take Alessandro to the emergency room. The couple, who work in accounting and finance in the Chicago area, were in Stockton, Calif., caring for Ms. Flores’s mother.
At the hospital, doctors presented the couple with several possible sources of his illness, which were “all terrible,” Ms. Flores said. Those included botulism or rare and serious degenerative or metabolic conditions.
They ordered a botulism antitoxin called BabyBIG from the California Department of Public Health, which had developed the treatment years before.
By Sunday evening, Alessandro was given the antitoxin and slowly began to improve. The state health department tested his stool and the family’s opened can of formula, discovering that both were positive for botulinum bacteria. The couple has filed a federal lawsuit against the company, claiming that it was negligent and sold an adulterated product.
Ms. Flores said the couple had chosen ByHeart’s formula because it was marketed as being close to breast milk, organic and the only option made from whole milk. But after their ordeal, she said, she felt guilty.
“We did all this research, we had trust in this company, and then all of a sudden, that’s the one thing you gave him and you kind of poisoned him,” she said. “I just felt like, that’s what I did.”
Ms. Flores said Alessandro is home from the hospital and his condition is steadily improving.
Dr. Jennifer Cope, who is leading an investigation into the outbreak for the Centers for Disease Control and Prevention, said that about 150 to 180 cases of infant botulism were reported to the agency each year. But an outbreak related to infant formula is unprecedented, she said.
It has left some infants so weak that they required intensive care or a breathing tube.
“We are hearing reports of infants recovering and going home,” she said, “and we haven’t had any deaths reported, which we are really, really glad to see.”
Ron Belldegrun, ByHeart’s chief executive, founded the company with Mia Funt, his sister, after a career in venture capital and hedge fund management. Ms. Funt had worked as a marketing and business development executive.
They have said that they were motivated to start the company after learning that the F.D.A.-approved recipe for infant formula was 15 years old, and that they had conducted clinical studies to get a new version approved. The company began selling directly to consumers in 2022 as families scrambled to find formula amid a major shortage that year.
Since then, the company has begun selling its formula on Amazon, at Target and at other major retailers.
On Thursday, ByHeart said in a statement that botulinum bacteria were not routinely tested for in infant formula. The company said it was working with the F.D.A. to determine how the bacteria entered the food supply and wanted to help advance testing standards.
Inspection reports show that the company has had manufacturing problems from the start. Inspections and a warning letter from the F.D.A. detailed concerns about cronobacter sakazakii, a bacterium that is deadly to babies and that was found at a company plant and in its finished formula. ByHeart reported to the agency that the findings were a result of contamination at a third-party testing lab, according to a warning letter issued by the F.D.A. The lab, which was not named in the letter, denied the claim.
Aside from the now-shuttered plant in Reading, Pa., the F.D.A. has also inspected the company’s Iowa and Oregon plants in recent days, taking finished cans of formula powder away for testing.
Representative Rosa DeLauro, Democrat of Connecticut, called on the F.D.A. to release its inspection reports about ByHeart facilities to her office.
Other families are also in the midst of caring for sick babies and helping them recover.
A lawsuit against the company filed by Stephen and Yurany Dexter of Arizona, describes how their daughter Rose, who was born in July, slowly lost her strength — until they could not rouse her. She was flown by air ambulance to Phoenix Children’s Hospital from a Flagstaff hospital.
The baby, who was treated with the antitoxin, has since returned home, but remains fussy and fearful when a parent is not in her view.
Colin and Jennifer Flowers, who live in Minnesota, are continuing to watch over their hospitalized baby daughter. The 3-month-old had been a happy baby, but became so weak that she stopped eating. Doctors performed a brain scan before treating her with the antitoxin.
Even then, her face remained paralyzed, and she required supplemental oxygen and a feeding tube, according to a lawsuit that her family filed in federal court in Minnesota.
The outbreak has alarmed some food safety experts, who said the F.D.A. should have learned more from the formula crisis of 2022, when sanitation problems and a whistle-blower complaint about an Abbott Nutrition factory in Michigan exacerbated shortages.
In the aftermath, the F.D.A. did recommend reforms in a report — one the agency should review carefully, said Susan Mayne, a former top agency official in the food division. Its subsequent effort, called Operation Stork Speed, to update the ingredients in infant formula did not deal with bacterial or other contaminant problems, she said.
“That report reflected tons of experience from what went wrong and what we need to do better,” she said. “And to just shelve it and totally ignore it with Operation Stork Speed is really shortsighted.”
Kyle Diamantas, who now heads the F.D.A.’s food division, represented Abbott Nutrition in litigation related to infant formula when he worked at the law firm Jones Day before joining the F.D.A. The agency has not responded to a request that has been pending for eight months to release the ethics agreement he was required to file that would govern his involvement in such matters.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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