Infant Botulism TREATMENT AND PREVENTION PROGRAM

Current Situation and Recall Update

As of November 8, 2025 CDPH is working with the CDC and FDA to investigate a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula.
CDPH’s Infant Botulism Treatment and Prevention Program (IBTPP), which developed and remains the world’s only source of the FDA-approved treatment for infant botulism (BabyBIG), identified an association between infant botulism cases and consumption of ByHeart formula.
The CDC publishes weekly updates of cases related to this outbreak. For the most current national case information, visit the CDC's Infant Botulism Outbreak Linked to Infant Formula page.
The investigation into lots of ByHeart powdered infant formula and other potential sources is ongoing.

ByHeart Recall

ByHeart Inc. has recalled all Whole Nutrition Infant Formula products. This includes all unexpired lots of formula cans and single-serve Anywhere Pack™ sticks.

The product was sold through ByHeart.com and major retailers including Amazon, Kroger, Walmart, Whole Foods, Target and Sam's Club.
Families should stop using ByHeart formula immediately and report any signs or symptoms of infant botulism to a health care provider or local health department.
According to the FDA, ByHeart formula accounts for less than 1 percent of U.S. infant formula sales and does not affect nationwide supply.

What Parents and Caregivers Should Know

If your baby has consumed ByHeart formula from the affected lots, watch for these early signs of infant botulism:

Difficulty feeding, sucking or swallowing
A weak cry
Decreased facial expression
Loss of head control
Overall muscle weakness
Constipation
Difficulty breathing

Severe cases can lead to a need for a tube down the baby's throat to help them get air for babies unable to breathe.

If not treated, it can lead to paralysis and death.

Seek medical care immediately if these symptoms appear and tell your provider that your baby consumed ByHeart formula.

Do not discard the container until you have spoken with your local health department, it may be needed for testing.

For help: Contact your child's health care provider right away.

About Infant Botulism

Infant botulism is a rare but serious illness caused when spores of Clostridium botulinum grow in a baby's intestine and produce toxin that weakens muscles.

Most cases occur in infants under one year old. With timely treatment, nearly all infants recover fully.

Laboratory and Diagnostic Testing

CDPH's Microbial Diseases Laboratory (MDL) performs testing for Clostridium botulinum toxin and spores in clinical and patient samples.

Testing supports outbreak investigations and confirmation of infant botulism cases.

For details on specimen collection, submission and shipping requirements, visit our Infant Botulism Laboratory and Diagnostic Information page.

Information for Health Care Providers

Report suspected cases immediately to your local health department.
If your patient is older than 15 months, please see Botulism Information for Health Professionals page for instructions on requesting antitoxin.
Call the IBTPP at (510) 231-7600 for consultation and BabyBIG® release.
Do not wait for lab confirmation before initiating consultation or treatment.

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