UPDATE: Public Health Alerts Parents and Caregivers to Infant Botulism Outbreak Linked to ByHeart Powdered Infant Formula - Hotline now available for concerned parents and caregivers

The Los Angeles County Department of Public Health is alerting parents and caregivers about an ongoing multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. Parents and caregivers should stop using ByHeart Whole Nutrition Infant Formula. Do not use recalled infant formula, which is listed below. Throw it away or return it to where you bought it. If possible, record the lot number.

Seek immediate medical care if an infant shows any of the following symptoms:

· Constipation

· Difficulty feeding, sucking, or swallowing

· Weak cry or diminished facial expression

· Poor head control

· Muscle weakness or trouble breathing

Currently, there is one confirmed case in Los Angeles County. The infant was hospitalized but is now recovering.

Nationwide, 13 suspected or confirmed infant botulism cases linked to ByHeart powdered formula have been reported across 10 states since August 2025. All 13 cases (100%) reported feeding ByHeart Whole Nutrition infant formula. There have been no deaths associated with this outbreak.

The California Department of Public Health’s (CDPH) Infant Botulism Treatment and Prevention Program, which operates the only source of infant botulism treatment worldwide, identified an increase in cases and first alerted the U.S. Centers for Disease Control and Prevention (CDC) to the outbreak. Public Health is coordinating closely with CDPH, CDC, the U.S. Food and Drug Administration (FDA), and other state and local health departments to monitor potential cases in Los Angeles County and ensure the availability of treatment. The investigation is ongoing.

Parents and caregivers with questions or concerns regarding the ongoing infant botulism outbreak can call CDPH’s new public-facing hotline. Caregivers can reach CDPH’s infant botulism experts directly at 1-833-398-2022, Monday through Sunday from 7 a.m. to 11 p.m.

About the Infant Formula

On November 11, 2025, ByHeart Inc. expanded its recall to include all ByHeart formula products nationwide, including cans and single-serve sticks.

The formula was sold through ByHeart.com and major retailers nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, and Sam’s Club. According to the FDA, ByHeart formula represents less than 1% of all U.S. infant formula sales, and the recall is not expected to create a national shortage.

CDPH tested a can of powdered infant formula consumed by an infant diagnosed with infant botulism, with preliminary results showing bacteria that produce botulinum toxin, consistent with confirmed cases.

Public Health is collaborating with CDPH and federal partners to ensure that any potentially contaminated product is removed from circulation and that infants showing possible symptoms are rapidly identified and treated.

What Parents/Caregivers Should Do

Parents and caregivers should stop using any ByHeart infant formula products immediately. This includes all lot numbers and all sizes of cans and single serve packets.

If possible, note the lot number and best by date. If you have leftover ByHeart powdered formula that your infant was fed, keep it stored for at least a month. If your infant develops symptoms of infant botulism, the state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.

Seek immediate medical care if an infant shows any of the following symptoms:

· Constipation

· Difficulty feeding, sucking, or swallowing

· Weak cry or diminished facial expression

· Poor head control

· Muscle weakness or trouble breathing

If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.

Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.

About Infant Botulism

Infant botulism is a rare but serious illness that occurs when spores of Clostridium botulinum colonize an infant’s intestines and produce botulinum toxin, leading to progressive muscle weakness and potential respiratory failure if untreated.

Healthcare providers are urged to report suspected cases immediately to their local health department to facilitate testing and access to treatment.

The only FDA-approved treatment for infant botulism, BabyBIG®, is produced by CDPH’s Infant Botulism Treatment and Prevention Program, which developed and supplies the treatment globally. BabyBIG® shortens hospital stays and significantly improves recovery for affected infants.

Public Health is ensuring rapid access to BabyBIG® for any potential cases in Los Angeles County. Physicians with suspected cases can contact the CDPH Infant Botulism Treatment and Prevention Program at (510) 231-7600 for immediate consultation.

Parents seeking guidance or concerned about possible exposure should contact their physician. They can also contact the Public Health InfoLine at 1-833-540-0473, open every day from 8 a.m. to 8 p.m., for assistance.

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