If you're a parent, caregiver, or someone who cares for an infant, recent news about infant botulism and powdered infant formula may have raised concerns. The California Department of Public Health wants to provide clear, accurate information to help you protect your baby's health.

What Happened: A Summary of the Investigation

In late 2025, California public health officials noticed an unusual increase in infant botulism cases. Through careful investigation, they identified a common link: many affected infants had been fed ByHeart brand powdered infant formula.

Key findings include:
- California's Infant Botulism Treatment and Prevention Program detected a rise in requests for BabyBIG, the only FDA-approved treatment for infant botulism
- Laboratory testing by CDPH found Clostridium botulinum—the bacteria that causes infant botulism—in an opened container of ByHeart formula fed to an ill infant
- An independent third-party lab, contracted by ByHeart, later confirmed the presence of Clostridium botulinum in multiple sealed containers of the formula
- Based on these findings, California, the CDC, and the FDA issued a national "Do Not Use" recommendation for ByHeart powdered infant formula
- ByHeart initiated a voluntary recall, first for specific lots and later expanded to all their powdered formula products

"We're incredibly proud of the public health investigation led by our Infant Botulism Treatment and Prevention Program and the Microbial Diseases Laboratory," said Dr. Erica Pan, State Public Health Officer and CDPH Director. "Their dedication to sound science identified ByHeart infant formula as the common thread in this outbreak and led directly to the prevention of more cases across the country."

What Is Infant Botulism?

Infant botulism is a rare but serious illness that affects babies under one year of age. It occurs when a baby swallows spores of a bacterium called Clostridium botulinum. These spores can grow in a baby's immature digestive system and produce a powerful toxin.

How the Toxin Affects Babies

Botulinum toxin blocks communication between nerves and muscles, leading to:
- Weakness or "floppiness" in the body
- Poor feeding or weak suck
- Constipation (often the first sign)
- Weak cry
- Drooping eyelids or decreased facial expression
- Difficulty breathing in severe cases

If untreated, infant botulism can lead to respiratory failure and can be life-threatening. However, with prompt medical care, most babies recover fully.

Why Babies Are Vulnerable

Infants under 12 months are at risk because:
- Their digestive systems are still developing and can't prevent bacterial spores from growing
- Their immune systems are not yet mature enough to fight off certain infections
- Older children and adults have mature gut flora that prevents these spores from taking hold

What Parents and Caregivers Should Do Now

If You Have ByHeart Formula at Home

Stop using it immediately. Do not feed any ByHeart powdered infant formula to your baby
Do not throw it away yet. Keep the product in its original packaging in case health officials need to test it
Contact ByHeart for information about returns or refunds
Switch to an alternative formula after consulting with your pediatrician

If Your Baby Has Been Fed ByHeart Formula

Watch for these warning signs of infant botulism:
- Constipation (no bowel movement for several days)
- Weakness or decreased movement
- Poor feeding or weak suck
- Weak cry or changes in cry
- Drooping eyelids or facial weakness
- Difficulty breathing or unusual breathing patterns

If you notice any of these symptoms:
1. Seek medical care immediately. Go to the emergency room or call your pediatrician right away
2. Tell healthcare providers that your baby has consumed ByHeart formula
3. Bring the formula container with you if possible, to help with investigation efforts

If Your Baby Shows No Symptoms

Even if your baby seems healthy after consuming ByHeart formula:
- Continue to monitor for symptoms for several weeks, as infant botulism can develop gradually
- Keep your pediatrician informed about the exposure
- Follow guidance from your healthcare provider about whether any additional monitoring is needed

Treatment and Recovery

BabyBIG: A Life-Saving Treatment

California developed and produces BabyBIG (Botulism Immune Globulin Intravenous, Human), the only FDA-approved treatment for infant botulism. Key facts about BabyBIG:
- It works by neutralizing the botulinum toxin in the baby's body
- Treatment with BabyBIG has been shown to significantly reduce hospital stays and healthcare costs
- California remains the only source of BabyBIG in the world
- The treatment is most effective when given early in the course of illness

What to Expect in the Hospital

If your baby is diagnosed with infant botulism:
- They will likely be admitted to a hospital, often to an intensive care unit
- Medical teams will monitor breathing closely and provide respiratory support if needed
- Feeding may be assisted through a tube if the baby has difficulty sucking or swallowing
- Most babies recover fully with appropriate care, though recovery can take weeks to months

Support for Families: Hotlines and Resources

For Parents and Caregivers

California has established a dedicated hotline to answer questions about infant botulism and the formula recall:

CDPH Public Infant Botulism Call Line
- Phone: 1-833-398-2022
- Hours: Monday–Friday, 8 a.m. to 5 p.m. PST
- Trained public health staff can provide information and guidance

For Healthcare Providers

Medical professionals can access 24/7 consultation for clinical guidance:
- CDPH medical staffing line operates around the clock for case consultation and treatment support
- Providers can coordinate access to BabyBIG when indicated

Additional Trusted Resources

CDC Infant Botulism Information: Science-based guidance on prevention, symptoms, and treatment
FDA Outbreak Updates: Current information on the formula investigation and recall status
Your pediatrician: Your child's healthcare provider is your best resource for personalized advice

Understanding Formula Safety: What This Means for Parents

Powdered Formula and Bacterial Risk

Powdered infant formula is not sterile. While manufacturers follow strict safety protocols, bacterial spores like Clostridium botulinum can occasionally contaminate products. This is rare, but it's why proper handling matters:

Always wash hands before preparing formula
Use water that is hot enough to kill potential contaminants (at least 158°F/70°C), then cool before feeding
Follow storage instructions carefully
Use prepared formula within recommended timeframes
Never save leftover formula from a feeding

Choosing Formula During Uncertain Times

If you're concerned about formula safety:
- Talk with your pediatrician about the best options for your baby
- Consider ready-to-feed liquid formula, which is commercially sterile
- If using powdered formula, follow safe preparation practices every time
- Keep records of lot numbers and purchase dates for any formula you use

Breastfeeding Support

For families who breastfeed or wish to start:
- Breast milk provides immune protection that can help guard against infections
- California offers free lactation support through many local health departments
- WIC programs provide breastfeeding counseling and resources
- Even partial breastfeeding can offer benefits alongside formula feeding

How Public Health Investigations Protect Families

This outbreak response demonstrates how public health systems work to protect communities:

Detection: Health programs notice unusual patterns in disease reports
Investigation: Teams work to identify common exposures and sources
Laboratory confirmation: Testing confirms suspected links between products and illness
Action: Recommendations, recalls, and treatments are deployed to stop further harm
Communication: Clear information is shared with families, providers, and the public

"California's commitment to protecting our communities from disease requires resources and the dedication of talented and compassionate individuals," Dr. Pan noted. "I cannot express how thankful I am to our staff for their commitment to our mission."

Questions Parents Often Ask

"How do I know if my baby has infant botulism?"

Early signs include constipation, weakness, poor feeding, and a weak cry. If you notice these symptoms, seek medical care immediately. Only a healthcare provider can diagnose infant botulism.

"Can infant botulism be prevented?"

While you can't eliminate all risk, you can reduce it by:
- Avoiding honey for babies under 12 months (a known source of botulism spores)
- Following safe formula preparation practices
- Keeping formula containers clean and properly stored
- Monitoring your baby's health and seeking care promptly for concerning symptoms

"Will my baby fully recover?"

With timely treatment, most babies recover completely from infant botulism. Recovery may take time—weeks to months—but long-term complications are rare when the condition is properly managed.

"Is all powdered formula unsafe?"

No. This investigation identified a specific issue with ByHeart brand powdered formula. Other brands continue to be monitored for safety. Always follow safe preparation practices regardless of brand.

Our Commitment to Families

At Crestwood General, we believe that parents and caregivers deserve clear, compassionate information during uncertain times. Infant health is precious, and navigating recalls or illness concerns can feel overwhelming.

You are your child's best advocate. Trust your instincts, ask questions, and lean on your healthcare team for support. Whether you need guidance on formula safety, help recognizing symptoms, or support accessing treatment, trusted resources are available.

If you have concerns about your baby's health, formula feeding, or infant botulism, talk with your pediatrician or contact the CDPH hotline at 1-833-398-2022. You're not alone—and help is always within reach.

Content provided by Crestwood General.