Executive Summary
- A multistate infant botulism outbreak with 13 suspected cases across 10 states has been linked to ByHeart Whole Nutrition Infant Formula.
- ByHeart Inc. has voluntarily recalled two lots: 206VABP/251261P2 and 206VABP/251131P2, both with a use-by date of Dec. 1, 2026.
- Health officials advise parents to stop using the formula immediately and seek medical care if infants show symptoms like constipation, weak cry, or muscle weakness.
- One confirmed case in Los Angeles County resulted in hospitalization, but the infant is now recovering.
The Los Angeles County Department of Public Health has issued an alert to parents and caregivers regarding a multistate outbreak of infant botulism connected to ByHeart Whole Nutrition Infant Formula. The warning follows a voluntary recall by ByHeart Inc. and is part of a coordinated response with the CDC and FDA after 13 suspected or confirmed cases were reported across 10 states.
Recall and Investigation Details
ByHeart Inc. voluntarily recalled two specific lots of its Whole Nutrition Infant Formula on November 8, 2025: Lot 206VABP/251261P2 and Lot 206VABP/251131P2, both with a use-by date of December 1, 2026. The formula was distributed nationwide through online sales and major retailers such as Target, Walmart, and Amazon. According to the FDA, the recall is not expected to cause a national shortage.
The investigation began after the California Department of Public Health’s (CDPH) Infant Botulism Treatment and Prevention Program identified an increase in cases and notified the CDC. Officials report that one confirmed case in Los Angeles County involved an infant who was hospitalized but is now recovering. Preliminary tests conducted by CDPH on a formula can consumed by an affected infant showed the presence of bacteria that produce botulinum toxin.
Symptoms and Official Recommendations
Infant botulism is a rare but serious illness caused by toxins from Clostridium botulinum spores, leading to muscle weakness and potential respiratory failure. Health officials urge parents and caregivers to seek immediate medical care if an infant displays symptoms such as constipation, difficulty feeding or sucking, a weak cry, poor head control, or muscle weakness.
Authorities advise consumers to immediately stop using all ByHeart Whole Nutrition Infant Formula and discard or return any recalled products. Any surfaces or items that may have come into contact with the formula should be washed with hot soapy water. Healthcare providers are urged to report suspected cases to their local health department to ensure rapid testing and access to the FDA-approved treatment, BabyBIG®, which is supplied globally by the CDPH program.