How to resolve AdBlock issue? LAKE COUNTY, Calif. — A multistate infant botulism outbreak that’s been linked to a New York company has led to a nationwide product recall, while county health officials say no cases have been reported locally.
The Lake County Department Health Services said it is monitoring developments related to the outbreak that’s been linked to select lots of ByHeart Whole Nutrition Infant Formula.
“At this time, all affected products have been removed from store shelves, and no cases have been reported locally,” the agency said in a Thursday statement.
The California Department of Public Health said 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula have been reported in 12 states: Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. Two cases each have been reported in California, Illinois and Texas.
As of Tuesday, 10 cases have been confirmed and five have testing underway, CDPH said.
On Nov. 8, ByHeart Inc. issued a voluntary recall of two lots of its Whole Nutrition Infant Formula: Lot 206VABP/251261P2 and Lot 206VABP/251131P2, both with use-by dates of Dec. 1, 2026.
ByHeart said the recalled formula was sold through ByHeart.com and major retailers nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target and SamsClub.com.
Then, on Tuesday, ByHeart announced it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack nationwide.
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have been investigating the infant botulism outbreak, which began over the summer.
The CDC said that, as of Tuesday — when the latest numbers were available — 84 infants nationwide have received treatment for infant botulism.
Infants with botulism show symptoms including constipation, poor feeding, loss of head control and difficulty swallowing in the initial stages, according to the CDC.
Without treatment, the CDC said the condition can advance to paralysis and breathing difficulties that require lengthy hospitalization and treatment with an intravenous medication called BabyBIG that’s used to treat infant botulism caused by botulinum toxin types A and B.
Among those babies receiving treatment, 36 had any powdered infant formula exposure and 15 consumed ByHeart Whole Nutrition infant formula.
With ByHeart brand formula being “disproportionately represented among sick infants in this outbreak,” while at the same time only representing an estimated 1% of all infant formula sales in the United States, the recall resulted.
The illnesses were reported between Aug. 9 and Nov. 10, with all 15 of the specific cases connected to ByHeart requiring hospitalizations, the FDA said. Those babies ranged in age from two weeks to five months old.
Officials said there have been no deaths to date.
In a Tuesday statement, ByHeart said it was alerted by federal health officials on Nov. 7. The following day, it announced its first voluntary recall.
The company said it’s taking the action in close collaboration with the FDA, “despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin.”
Lake County Health Services said it will continue to monitor the situation closely and share updates as they become available.
“At this time, the outbreak does not pose any concerns regarding infant formula shortages for parents and caregivers,” the agency said.
Parents or caregivers with concerns about the recalled formula may visit the FDA or CDPH website or contact their healthcare provider for guidance.
ByHeart also is offering information and support for parents here.
The CDC estimates that one half of all infants under one year in the United States depend on infant formula.
Because of the large number of infants that require it and the small number of producers nationwide, a 2022 shortage hit the nation particularly hard.
The shortage began late the previous year due to supply chain issues arising from the COVID-19 pandemic, which were exacerbated when Abbott Nutrition — a key baby formula manufacturer — pulled produce from the shelters and stopped production at a Michigan plant following an FDA investigation into foodborne illness, according to a paper published by the National Library of Medicine.
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