Key Takeaways
- 13 infants across 10 states sickened by botulism linked to ByHeart formula
- California’s unique program detected outbreak through increased anti-toxin requests
- Two specific lots voluntarily recalled; parents urged to check and discard cans
- No deaths reported; investigation ongoing nationwide
Health officials have issued urgent warnings about ByHeart Whole Nutrition Infant Formula linked to a botulism outbreak affecting 13 babies across 10 states, including one case in Los Angeles County. The contamination was first identified by California’s specialized Infant Botulism Treatment and Prevention Program, which noticed unusual demand for its anti-toxin treatment in August.
Outbreak Detection and Response
The California Department of Public Health alerted the CDC after observing increased requests for BabyBIG, the only FDA-approved anti-toxin for infant botulism. This triggered a nationwide investigation that continues to unfold. Major retailers including Amazon, Target, Walmart and Whole Foods have been asked to remove the product from shelves.
Jemma Alarcon, medical director of LA County’s Food and Water Safety unit, advised parents: “We’re recommending they either return it to where they got it for reimbursement, or just throw it away. If you see symptoms like sleepiness, lethargy, constipation, or the baby isn’t acting normally, go to the emergency room or your doctor immediately.”
Recall Details and Symptoms
ByHeart voluntarily recalled two lots on Saturday:
- Lot 206VABP/251261P2 (Use by 01 Dec 2026)
- Lot 206VABP/251131P2 (Use by 01 Dec 2026)
Additional symptoms parents should watch for include:
- Difficulty feeding, sucking or swallowing
- Weak cry or diminished facial expression
- Poor head control
- Muscle weakness or trouble breathing
Company Response and Regulatory Context
ByHeart acknowledged the recall but noted the tested formula came from a previously opened can. The company stated: “Clostridium botulinum exists naturally in soil, dust and vegetables, meaning opened cans can be contaminated multiple ways.” They emphasized that global authorities don’t recommend testing infant formula for the bacteria.
Of the 13 cases, nine are confirmed and four pending investigation. The FDA notes the product represents less than 1% of US infant formula sales. No deaths have been reported.
Understanding Infant Botulism Risks
Botulism affects infants differently than adults. While adults must ingest the toxin itself, infants can become ill simply by consuming the bacterial spores, which then produce toxin in their immature digestive systems.
Food safety attorney Bill Marler, representing an Arizona infant hospitalized for two weeks, explained: “Botulism spores are pretty tough to kill, even with hot water used for formula preparation. They’re hardy and could enter through various contamination points in manufacturing.”
Although rare, untreated botulism can cause respiratory failure and death. Health officials continue to investigate how the contamination occurred in this nationwide outbreak.
