ByHeart recalls formula as federal officials probe infant botulism cases

Posted by Donovan Quintero | Nov 9, 2025 | News |

A national infant botulism investigation that includes one confirmed case in Arizona has led to a voluntary recall of two batches of ByHeart infant formula, prompting warnings across 10 states.

The Food and Drug Administration is reviewing 83 infant botulism cases reported since August 2025, noting that 13 of the infants had consumed ByHeart Whole Nutrition Infant Formula before becoming sick. No deaths have been reported.

The Centers for Disease Control and Prevention confirmed that all affected infants were hospitalized and treated with BabyBIG, a specialized antitoxin for infant botulism.

Federal investigators have not found a direct link between ByHeart formula and the illnesses. No ByHeart samples tested to date have contained botulinum toxin or Clostridium botulinum. Testing of the formula and manufacturing environments is ongoing.

ByHeart voluntarily recalled two batches – Lot 251261P2 and 251131P2, each with a use-by date of Dec. 1, 2026, and UPC 5004496800 – after the FDA expanded its investigation. Company co-founders Mia and Ron said the recall was made “out of an abundance of caution” to prioritize infant safety, even though regulators have not identified contamination.

“We removed these batches to eliminate any possible risk and protect every baby who uses ByHeart, including our own,” they said. “The FDA has never found a direct link between infant formula and infant botulism, and no related toxins have been found in any ByHeart product.”

Infant botulism occurs when swallowed spores from Clostridium botulinum grow in a baby’s large intestine and begin producing toxin, according to the CDC. The illness often begins with constipation, followed by difficulty feeding, weak cry, drooping eyelids and loss of muscle tone. If untreated, it can lead to breathing problems.

International food-safety agencies consider powdered infant formula very low-risk for botulism because of strict hygiene controls, the company noted.

Parents and caregivers are urged to check batch numbers, stop using recalled cans, and seek medical attention if an infant shows symptoms. ByHeart is offering replacement product and support through hello@byheart.com.

The CDC and FDA continue to investigate and will provide updates as testing progresses.
Other cases were reported in California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

State and local health officials are interviewing caregivers about foods given in the month before illness. All 13 infants reported feeding on ByHeart Whole Nutrition Infant Formula, the CDC stated on its website.

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