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California investigates infant botulism outbreak linked to recalled formula
botulism
ByHeart Whole Nutrition Infant Formula is linked to a botulism outbreak.

SACRAMENTO — California public health officials are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula, prompting an urgent recall and warnings to parents nationwide.

The California Department of Public Health (CDPH) alerted the U.S. Centers for Disease Control and Prevention (CDC) after noting a rise in infant botulism cases associated with the powdered formula. CDPH, CDC, and other state health departments are now investigating 13 suspected or confirmed cases across 10 states. Eight cases have been confirmed as toxin type A botulism, with additional test results pending.

On Nov. 8, ByHeart Inc. voluntarily recalled two lots of its Whole Nutrition Infant Formula:

  • Lot 206VABP/251261P2 (“Use by 01 Dec 2026”)
  • Lot 206VABP/251131P2 (“Use by 01 Dec 2026”)

The formula was sold online at ByHeart.com and through major retailers including Amazon, Kroger, Walmart, Whole Foods, Target, and Sam’s Club. According to the U.S. Food and Drug Administration, ByHeart formula accounts for less than 1 percent of U.S. infant formula sales and the recall is not expected to impact national supply.

CDPH tested a can of formula consumed by one of the affected infants and found preliminary evidence of bacteria that produce botulinum toxin, consistent with the confirmed cases.

“Infant botulism is a very rare disease that can cause progressive muscle weakness, including difficulty breathing if not treated promptly,” said Dr. Erica Pan, CDPH Director and State Public Health Officer. “We are urging parents to stop using ByHeart formula immediately.”

Symptoms of infant botulism may include constipation, poor feeding, weak cry, diminished facial expression, and poor head control. Parents noticing these signs should seek medical care immediately and retain the formula packaging for investigation. Healthcare providers are urged to report suspected cases to local health departments to expedite testing and treatment.

CDPH continues to test suspected products and monitor cases through its Infant Botulism Treatment and Prevention Program, which developed BabyBIG—the only FDA-approved antitoxin for infant botulism. BabyBIG has been shown to reduce hospital stays and treatment costs and remains the global standard for care.

Physicians can reach the program at (510) 231-7600 for consultation. Parents with concerns should contact their healthcare provider without delay.

Infant botulism occurs when spores of Clostridium botulinum colonize a baby’s large intestine and produce toxin, leading to muscle weakness and, in severe cases, respiratory failure.

For more information on the recall and safe disposal of affected formula, visit the FDA or CDPH websites.