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Powdered whole milk used to make ByHeart infant formula could be linked to the recent outbreak of botulism that has sickened dozens of babies, US health officials said Friday.

Testing by the Food and Drug Administration (FDA) found the bacteria that can cause the illness in two samples connected to the formula.

The FDA reported that bacteria in an unopened can of ByHeart formula matched a sample from a sick baby.

The same bacteria also appeared in samples of organic whole milk powder used to make the formula and collected by the company.

Testing confirmed that a sample of the powdered milk supplied to ByHeart matched the germ in a finished can of formula.

"These findings suggest we are significantly closer to determining the root cause of the contamination," ByHeart officials said in a statement. FDA added that the investigation is ongoing to fully determine the source. Neither agency revealed the supplier of the powdered milk.

Dr. Devon Kuehn, ByHeart's chief scientific and medical officer, described the discovery as a "watershed moment" for the company, ABC News reported.

"We are focused on the root cause and our responsibility to act on what we've learned to help create a safer future for ByHeart and infant formula," Kuehn said.

The outbreak has affected 51 babies in 19 states since December 2023.

Officials first noticed the problem in November after the California program that provides the only treatment for infant botulism observed a rise in cases among babies who consumed ByHeart formula.

No new cases have been reported since mid-December, according to the US Centers for Disease Control and Prevention (CDC).

ByHeart Formula Recall Now Covers All Products

ByHeart initially recalled two lots of formula but quickly expanded the recall to all products. Federal health officials said they could not rule out contamination of products made since the company launched in March 2022.

Earlier testing by the company found six out of 36 formula samples from three different lots contained the bacteria that causes infant botulism.

Experts say illnesses from botulism bacteria in infant formula are rare, making this outbreak unusual in size and scope.

According to AP News, Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, said, "FDA has not announced a plan to do testing, and that's what we really want to see them do."

Even if contamination comes from a milk supplier, the company remains responsible, noted Seattle food safety lawyer Bill Marler, who represents more than 30 families affected by the outbreak.

"Pointing to the dried powder doesn't take away ByHeart's legal or moral responsibility," he said.

ByHeart, which accounted for about 1% of the US infant formula market, previously sold roughly 200,000 cans per month.

Parents chose the formula, priced at about $42 per can, because it uses "organic, grass-fed whole milk" and is marketed as close to human breast milk.

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