When news breaks about baby formula recalls or rare infant illnesses, it’s only natural for parents to feel a jolt of worry. Recently, health officials in the U.S. have been investigating an outbreak of infant botulism linked to By Heart’s powdered infant formulas, and some products have been recalled as a result.

The good news: Infant botulism is very rare. And when it does happen, most babies who receive prompt care recover fully. Still, it’s important to know what infant botulism is, what symptoms to watch for, how to prevent it, and what to do if your baby may have been exposed.

What is infant botulism?

“Botulism” is a serious illness caused by a toxin produced by certain bacteria called Clostridium botulinum (and a few closely related species). The toxin affects the nerves and can lead to muscle weakness, paralysis, and trouble breathing.

Infant botulism is a special form of the illness that happens only in babies. Instead of getting sick from pre-formed toxin in food (like adults do), babies swallow bacterial spores that then germinate in their intestines and start making toxin right inside the gut.

How do babies get infant botulism?

Babies can swallow C. botulinum spores from a few different sources:

• Honey: Honey is the one clearly proven food that can carry botulinum spores and cause infant botulism. That’s why the American Academy of Pediatrics (AAP) says no honey for babies under 12 months, in any form (in food, in tea, or on a pacifier).
• Soil and dust: Spores live naturally in soil and dust. Microscopic particles can float in the air and land on surfaces—or on baby’s hands, toys, or pacifier—which could then end up in the mouth.
• Other foods: Most infant botulism cases are not tied to a specific food. However, there have been rare cases associated with foods like herbal teas or, as in the current outbreak, powdered infant formula.

You cannot tell if something has botulism spores by looking, smelling, or tasting it. Spores don’t change the look, smell, or taste of food.

Is infant botulism contagious?

No. Infant botulism does not spread from person to person. You don’t have to isolate your baby from siblings or family if they are being evaluated or treated for infant botulism. 

Who is most at risk for botulism?

Infant botulism is still very rare, but some babies are more likely to get it than others. Based on CDC and AAP data, some factors include:

• Age: Most cases occur in babies younger than 6 months. The risk continues (though is lower) up to 12 months of age.
• Environment: Babies who live in areas with a lot of soil, dust, or construction might be more likely to swallow spores in the air.
• Diet: Babies who are fed honey or foods/products containing honey before 12 months are at increased risk.

Even so, infant botulism is generally uncommon. For example, in one recent year, there were about 150 infant botulism cases in the entire United States, making up roughly 70% of all reported botulism cases—but that’s still only a tiny fraction of all babies.

Both breastfed and formula-fed babies can develop infant botulism. Feeding type alone does not cause or prevent the condition.

Signs and Symptoms of Infant Botulism

Infant botulism can start with subtle changes that are easy to overlook at first. Symptoms usually appear 3 to 30 days after spores are swallowed. Common early signs include:

• Constipation: This is often the first sign, especially if your baby was previously pooping regularly.
• Poor feeding: This may look like a weaker suck, difficulty breastfeeding or taking a bottle, or taking much longer to feed than usual.
• Weak or different-sounding cry
• Floppiness (low muscle tone): Your baby feels “heavier” or more like a rag doll when you pick them up or you may notice they’re having trouble holding up their head.
• Less facial expression: Your baby has a “blank” or less animated face or droopy eyelids.
• Excess drooling or pooling of saliva
• Lethargy: Your baby is sleepier than usual and/or is harder to wake for feeds.
• As the illness progresses, more serious symptoms can appear:
• Trouble swallowing
• Breathing difficulty (fast, shallow, or labored breathing)
• Pauses in breathing (apnea)
• Generalized weakness that starts in the face and moves downward through the body

Any sudden change in your baby’s feeding, muscle strength, or alertness—especially combined with constipation—merits a call to your pediatrician!

How is infant botulism diagnosed?

If your pediatrician suspects infant botulism, they’ll carefully review your baby’s symptoms and history (including diet and any exposures). Then, they’ll perform a full physical exam, with close attention to muscle tone, reflexes, and breathing.

To confirm the diagnosis, doctors may send a stool sample (or sometimes an enema specimen) to a specialized public health laboratory to look for C. botulinum toxin or spores. However, treatment is usually started before test results come back because waiting could be dangerous.

How is infant botulism treated?

Infant botulism is considered a medical emergency, and babies are usually treated in the hospital—often in a pediatric intensive care unit (PICU). Treatment may include:

Supportive Care

• Breathing support: Some babies need help breathing with oxygen or a ventilator (breathing machine) until their muscles recover.
• Feeding support: Babies may need IV fluids or a feeding tube if they cannot safely suck and swallow.
• Monitoring: Careful watching of breathing, heart rate, and muscle strength.

BabyBIG (Botulism Immune Globulin)

A special medication called BabyBIG (Botulism Immune Globulin Intravenous) is the only FDA-approved treatment for infant botulism types A and B in the U.S. BabyBIG is an IV medicine made from antibodies that bind to the botulinum toxin, stopping it from causing more damage. It doesn’t instantly reverse weakness, but it shortens the illness and hospital stay and helps babies recover faster.

BabyBIG is supplied only through the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP), which works with doctors across the country.

Recovery

Even with treatment, recovery can take weeks to months, because nerves must slowly heal. The encouraging news? With prompt treatment and good supportive care, most babies recover fully with no long-term neurologic problems.

How to Help Prevent Infant Botulism

You can’t completely “sterilize” your baby’s world (and you don’t need to!), but there are practical steps that reduce risk…

Avoid honey for the first year.

Do not give your baby honey or foods/drinks containing honey before 12 months, and do not dip your baby’s pacifier in honey or honey-based products. Honey isn’t safe for kids until after their first birthday.

Practice good food safety.

For babies and the whole family:

• Wash fruits and vegetables well before serving.
• Follow safe handling and storage directions on packaged foods.
• If you do home canning, follow U.S. Department of Agriculture guidelines and use proper pressure canning techniques (especially for low-acid foods like meats and vegetables).
• Throw away cans or jars that are bulging, leaking, cracked, or spraying liquid/foam when opened. Never “taste test” food to see if it’s safe.

Keep baby gear clean.

Wash bottles, nipples, and pacifiers daily with hot, soapy water or in the dishwasher (if dishwasher-safe), and clean feeding surfaces regularly.

Remember, aside from honey, most infant botulism cases are not linked to a specific food you can completely avoid. Dust and soil are part of the world, and that’s okay. The goal is to reduce avoidable risks while not driving yourself bananas trying to eliminate every speck of dirt. 

What to Do If There’s a Botulism Outbreak or Recall

Hearing about an outbreak tied to a baby product can be truly frightening. Here’s a calm, step-by-step approach recommended by public health agencies like CDC and the California Department of Public Health.

Check whether your baby’s product is affected.

Look up the official recall notice from the FDA or your country’s food-safety agency. Compare the brand, product name, lot/batch numbers, and “use by” dates on your formula or food packaging to the recall details.

Authoritative resources for this info include the CDC’s botulism pages and outbreak updates and the Infant Botulism Treatment and Prevention Program (IBTPP).

Stop using recalled products immediately.

Do not feed the recalled formula or food to your baby (or anyone else)! Follow the disposal or return instructions in the recall notice or from the manufacturer.

Save packaging if advised.

Public health officials sometimes ask families to keep leftover product and packaging (including lot numbers) for possible testing if a baby becomes ill. Follow the directions in the recall or from your local health department.

Clean feeding equipment and surfaces.

Wash bottles, nipples, scoops, counters, and any surfaces that may have touched the recalled product with hot, soapy water, and rinse well.

Watch your baby closely for symptoms.

For about 30 days after your baby last consumed an implicated product, keep an extra-close eye on your baby for symptoms of botulism, such as changes in feeding, new or worsening constipation, floppiness or loss of head control, a weak cry, or reduced facial movement. If you notice any of these signs, call your pediatrician right away (or seek emergency care if severe!).

When to Call your Doctor

Be sure to tell your doctor if your baby has been exposed to honey, fed a product involved in a botulism recall, or living in or visiting areas with a lot of dust or soil. This information helps your child’s provider decide how urgently your baby needs to be seen and whether they should be evaluated for infant botulism.

When to Call 911 or Go to the Emergency Room

Call 911 (or your local emergency number) right away if your baby has:

• Trouble breathing (Look for rapid, labored, or very shallow breaths as well as grunting, nostril flaring, or ribs pulling in with each breath)
• Blue, gray, or very pale lips, tongue, or face
• Extreme floppiness or won’t wake up or respond normally
• Sudden difficulty swallowing, choking repeatedly on feeds, or large amounts of drool they can’t manage

These are signs of a medical emergency, and your baby needs immediate care—don’t drive far or wait to “see if it gets better.”

The Bottom Line

Infant botulism is scary to hear about, especially when it’s in the news, but most of the time, it’s very rare, and most babies will never encounter it. And if a baby does get infant botulism, early treatment and supportive care mean that the vast majority recover completely.

And remember: You don’t need to figure this out alone. If something about your baby’s feeding, poop, or behavior is making your parent-spidey-sense tingle, reach out to your pediatrician. They’d always rather you call with a concern than wait and worry at home.

 

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REFERENCES

• U.S. Food and Drug Administration: Outbreak Investigation of Infant Botulism — Infant Formula (November 2025)Centers for Disease Control and Prevention: Infant Botulism Outbreak Linked to
• Infant Formula (November 2025)
• U.S. Food and Drug Administration: Response to Broader FDA Investigation — ByHeart Initiates Voluntary Recall of Two Batches of Infant Formula
• Centers for Disease Control and Prevention: About Botulism
• World Health Organization: Botulism — Fact Sheet
• Centers for Disease Control and Prevention: Clinical Overview of Infant Botulism — Botulism for Health Care Providers, April 2024
• American Academy of Pediatrics: Botulism — Infections in Young Children
• Infant Botulism Treatment & Prevention Program: Honey and Infant Botulism (Parent Information)
• California Department of Public Health: Botulism Fact Sheet (PDF)
• Cleveland Clinic: Infant Botulism — Causes, Symptoms & Treatment
• Poison Control: Don’t Feed Honey to Infants
• Children’s Hospital of Philadelphia: Infant Botulism — History & Physical Exam
• California Department of Public Health: BabyBIG® for Infant Botulism
• MSD Manuals Professional Edition: Infant Botulism — Anaerobic Bacteria
• University of Florida IFAS Extension: Infant Botulism — Fact Sheet AA142

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Disclaimer: The information on our site is NOT medical advice for any specific person or condition. It is only meant as general information. If you have any medical questions and concerns about your child or yourself, please contact your health provider.