More formula recalled from Walmart, Publix, others. Botulism infects more babies

David J. Neal, Miami Herald on Nov 11, 2025

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After the FDA learned of infant botulism infecting two more babies, New York City-based ByHeart recalled all of its formula products nationwide on Tuesday.

The recall reaches all Walmart stores, Walmart.com and SamsClub.com; Kroger and Kroger-owned chains Fred Meyer, QFC and Smith’s; Target; Meijer; and Publix, among national chains.

“At this moment, the most important thing for you to know is that all ByHeart product must be discarded,” ByHeart posted to its website Tuesday.

The federal Centers for Disease Control and Prevention recommends that anyone with the formula should record the lot number and best by date.

“If you have leftover ByHeart powdered formula that your infant was fed, keep it stored for at least a month,” the CDC said. “If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.”

Tuesday’s action expanded Friday’s recall of two batches of ByHeart Whole Nutrition Infant Formula.

ByHeart said Tuesday’s decision was made after notification late Monday from the U.S. Food and Drug Administration about two more babies infected with infant botulism that had consumed ByHeart formula.

“It’s important that you know that neither we, nor the FDA nor the CDC, have found clostridium botulinum spores or toxins in any unopened can of ByHeart formula,” ByHeart said.

But on Friday, the state of California said, “Preliminary testing of one sample of the formula by the (California Department of Public Health) laboratory suggests the presence of the bacterium that causes botulism.”

Update on the infant botulism outbreak

Monday’s FDA outbreak update said, with the two latest sick babies, “15 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 12 states.”

All 15 kids have been hospitalized.

Two babies each have been sickened in California, Texas and Illinois. There’s one baby each in North Carolina, Washington, Kentucky, Pennsylvania, Arizona, Minnesota, New Jersey, Oregon and Rhode Island.

“Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing,” the CDC said. “If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.”

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