Health officials are warning parents to avoid using infant formula linked to a nationwide botulism outbreak.
As of November 10, 13 infants in 10 states, including one in Los Angeles County, became ill with bacterial spores after drinking ByHeart Whole Nutrition infant formula.
There were cases first identified by the California Department of Public Health.
The state has the Infant Botulism Treatment and Prevention Program, the only manufacturer and supplier of an FDA-approved antitoxin for the treatment of infant botulism. Officials were alerted to the outbreak when they noticed an increase in requests for BabyBIG antitoxin in August of this year, according to Robert Barsanti, a health department spokesman.
The state alerted the U.S. Centers for Disease Control and Prevention and prompted a nationwide investigation that is ongoing.
Health officials ask major retailers such as Amazon, Target, Walmart and Whole Foods must remove the product from their shelves. They are also asking parents and guardians to check their infant formula and throw away any cans made by ByHeart Inc.
If a parent or guardian thinks they may have a child with botulism who has ingested baby food, take a photo of the jar and lot number, said Gemma Alarcon, medical director of the Los Angeles County Department of Public Health's Division of Food and Water Safety.
“We recommend that they either return it to where it was received to get a refund or just throw it away,” she said. “It is very important that if you see symptoms such as drowsiness, lethargy, constipation, or your baby is not acting like themselves, simply go to the emergency room, contact your healthcare provider and let them know that your baby is consuming this formula.”
In the press release, county health officials also cited symptoms such as difficulty feeding, sucking or swallowing; faint cry or worsened facial expression; poor head control; and muscle weakness or breathing problems.
On Saturday, ByHeart voluntarily recalled two lots of contaminated infant formula: Lot 206VABP/251261P2 (use by December 1, 2026) and Lot 206VABP/251131P2 (use by December 1, 2026).
No deaths associated with the outbreak have been reported.
The product accounts for less than 1% of all baby food sales in the United States, according to the FDA.
Nine of the 13 cases in the outbreak have been confirmed so far; four are pending. They all involve the same formula and the same strain of bacteria.
Company This is stated in the message on the website that the company voluntarily recalled the batches, but noted that the powder mixture tested by the California Department of Public Health came from a can that had previously been opened.
“We know that Clostridium botulinum “is a bacterium that exists naturally in the environment—in places like soil, dust, and even vegetables—which means an opened can can become contaminated in a variety of ways,” the company's website says.
It also notes that “global regulatory and scientific bodies do not recommend testing powdered infant formulas for Clostridium botulinumand no US or global infant formula company tests Clostridium botulinum“
The spores produced by botulism bacteria are heat-stable and widely distributed in the environment. In the absence of oxygen, they germinate, grow and then release toxins.
Although this disease is rare, it is associated with improper food processing that allows bacterial spores to survive and grow. If left untreated, the toxin can lead to respiratory failure and death.
The disease is acquired differently in infants than in adults. To become infected, an adult must ingest the toxin. Babies, on the other hand, can get sick simply by ingesting the bacterium because, due to their immature immune system, it will develop into a toxin in their intestines.
Bill Marler, an attorney at Marler Clark, a food safety law firm, said cases of infant botulism are extremely rare. He said he had a client in Arizona whose baby was hospitalized for two weeks and placed on a feeding tube for four weeks after ingesting allegedly contaminated ByHeart formula.
He said botulism spores are linked to cleanliness deficiencies in food production lines. However, once they take up residence in a food source, they are difficult to get rid of.
“Botulism spores are quite difficult to kill, even with hot water that you add to baby food,” he said. “These spores are tough little guys. They could have landed on, you know, someone's shoes or a pallet or, you know, something like that.”»
