If parents suspect their child or a doctor suspects a child has developed infant botulism, particularly in relation to consuming ByHeart formula or any other food source, it’s important to take the situation seriously. Here are several key points parents and doctors should be aware of:
Incubation Period: The incubation period for infant botulism can vary, but it is generally considered to be between 3 to 30 days after exposure to the botulinum spores. Most cases typically present symptoms within 1 to 2 weeks after exposure. However, because infant botulism is caused by the ingestion of spores that then germinate and produce toxin in the infant’s intestines, the exact timing can depend on various factors, including the amount of spores ingested and the individual infant’s gut environment.
Recognizing Symptoms: Infant botulism typically occurs in infants under one year of age. Symptoms may include:
– Constipation (often the first sign)
– Weakness or lethargy
– Poor feeding or difficulty sucking
– Floppy movements (hypotonia)
– Weak cry
– Difficulty swallowing
– Drooling
– Respiratory distress
Immediate Action: If you suspect your child may have symptoms of botulism, seek medical attention immediately. Botulism can be a medical emergency, especially in infants.
Diagnosis: A healthcare provider can diagnose infant botulism through clinical evaluation and may perform tests to confirm the presence of the botulinum toxin or spores.
Treatment: Treatment for infant botulism typically involves hospitalization and supportive care. In some cases, healthcare providers may administer an antitoxin – BabyBIG, but the most critical aspect is supportive care, including monitoring and managing respiratory function.
Reporting: If you believe your child’s condition is related to ByHeart formula, it is important to report this to your healthcare provider – Hotline. This can help in tracking potential outbreaks and ensuring product safety.
Stay Informed: The CDC, FDA and CDPH are updating this fast moving outbreak frequently.
The latest from the CDPH Infant Botulism Treatment and Prevention Program
Important Notice
The Infant Botulism Treatment and Prevention Program (IBTPP) is currently receiving a very high volume of calls and emails.
- Parents and caregivers: For questions related to ByHeart formula or infant botulism, please call the toll-free Infant Botulism Outbreak Hotline at 1 (833) 398-2022. The hotline is open 7 days a week from 7 a.m. to 8 p.m. Pacific Time (PT).
- Health care providers: Please continue to use the IBTPP clinical support line (510) 231-7600 for suspected infant botulism cases. Provider calls requesting treatment will receive priority response.
If your child has clinical signs or you’re concerned about their health, contact your health care provider. In an emergency, seek medical care immediately.
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:
- Constipation
- Weak cry or poor head control
- Difficulty feeding, sucking or swallowing
- Diminished facial expression
- Muscle weakness or trouble breathing
Seek medical care immediately if any of 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.
For questions: About ByHeart formula or infant botulism, please call the toll-free Infant Botulism Outbreak Hotline at 1 (833) 398-2022.
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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