Flash botulism poisoning among infants The number of children fed ByHeart formula increased to 15 children in 12 states.
A spokesman for the California Department of Public Health confirmed the new numbers to The Associated Press.
The Food and Drug Administration declared the outbreak on Saturday. At that time, there were 13 infants with botulism poisoning in 10 states. All were fed ByHeart formula, and all 15 children now known to have botulism were hospitalized, according to the Centers for Disease Control and Prevention.
The company has recalled two batches of the formula: 206VABP/251261P2 and 206VABP/251131P2 with an expiration date of December 2026. The formula was sold through ByHeart.com and major retailers nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target and Sam's Club.
There are concerns that consumers may have the recalled formula in their homes due to its long shelf life. Public health officials urge consumers to check their homes for the recalled lots and stop using them immediately.
Typical signs and symptoms of infant botulism often begin with constipation, difficulty feeding (sucking and swallowing), poor head control, weak and altered crying, worsening facial expressions, and other signs of muscle weakness.
Once early symptoms appear, infants may have trouble breathing, which can quickly lead to death.
The outbreak began in mid-August. No deaths were reported.
On Nov. 7, the New York-based company was notified by the Food and Drug Administration of approximately 83 cases of infant botulism reported nationwide since August 2025, according to ByHeart.
Known patients in the outbreak range in age from 2 weeks to 5 months. Infants were hospitalized after consuming ByHeart powder formula, according to the US Centers for Disease Control and Prevention.
California officials have confirmed that a sample from an open can of ByHeart baby food that was fed to an ill infant contained a type of bacteria that causes a toxin linked to the outbreak.
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