Health Alert: ByHeart Infant Formula Linked to Multi‑State Botulism Outbreak — Check and Discard Recalled Lots

Investigation Links ByHeart Formula to Rare Infant Botulism Cases

Health officials are urging parents and caregivers to stop using certain lots of ByHeart Whole Nutrition Infant Formula after investigators linked a rare outbreak of infant botulism to the product. As of Nov. 10, 13 infants in 10 states — including one in Los Angeles County — have become ill after consuming the formula. Nine cases are confirmed and four are pending. No deaths have been reported.

How the outbreak was detected

The California Department of Public Health identified the early cases and alerted federal partners after staff at its Infant Botulism Treatment and Prevention Program noticed an increase in requests for BabyBIG, the FDA‑approved anti‑toxin for infant botulism. The state notified the U.S. Centers for Disease Control and Prevention, which helped launch a nationwide investigation that is ongoing.

Recall and retail actions

ByHeart voluntarily recalled two powder formula lots associated with the investigation:

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

Health officials have asked major retailers — including Amazon, Target, Walmart and Whole Foods — to remove the product from their shelves. The FDA estimates the product represents under 1% of U.S. infant formula sales.

What caregivers should do now

If you have this formula, officials recommend:

• Photograph the can and lot number and keep those records.
• Return the can to the place of purchase for a refund or discard it safely.
• Seek immediate medical care if your baby shows warning signs (see symptoms below) and tell clinicians the infant consumed this formula.

"We're recommending they either return it to where they got it, so they can get a reimbursement, or they can just throw it away," said Jemma Alarcon, medical director of the Los Angeles County Department of Public Health's Food and Water Safety unit.

Symptoms of infant botulism

County health officials advise caregivers to watch for: sleepiness or lethargy; constipation; difficulty feeding, sucking or swallowing; weak cry or diminished facial expression; poor head control; muscle weakness; and trouble breathing. If you observe any of these signs, seek emergency care immediately.

About the bacteria and company statement

Clostridium botulinum spores are widespread in the environment — in soil, dust and on produce — and are heat resistant. In an oxygen‑free environment the spores can germinate, grow and produce toxins. Infants can become ill after ingesting the bacterium because their immature gut can allow spores to produce toxin, whereas adults usually must ingest preformed toxin to become sick.

ByHeart said the powdered sample tested by the California Department of Public Health came from a can that had previously been opened and noted that global authorities do not recommend routine testing of powdered infant formula for C. botulinum. The company has voluntarily recalled the two lots listed above.

Context and expert comment

Bill Marler, an attorney at food‑safety law firm Marler Clark, said infant botulism is rare but serious. He described a case in which an infant required hospitalization and a feeding tube after allegedly consuming contaminated formula, and noted that spores can be difficult to eliminate once established in a food production environment.

Investigations are ongoing. Officials continue to trace the source and scope of the outbreak. Caregivers should follow recall guidance and contact their health provider or emergency services if they suspect exposure or see symptoms.

This article is based on reporting from the California Department of Public Health, the U.S. Centers for Disease Control and Prevention, the Food and Drug Administration and statements from ByHeart and public health officials.