Important Notice​

Frequently Asked Questions (FAQs)

General Questions

What is infant botulism?

• Infant botulism is a rare, but serious illness. It is caused by a toxin that attacks the body's nerves. It happens to babies one year old or younger.
• It is caused when babies swallow something that has the toxic bacterium in it. This can include honey or contaminated formula.
• This bacterium can damage nerves and make it hard for babies to move their muscles. The illness gets worse over time. Babies might seem floppy.
• Babies with signs should get medical care quickly. The illness is treatable, and most babies fully recover.
  

How does infant botulism affect my baby?

Babies get sick when they swallow spores of a particular bacterium, Clostridium botulinum. This bacterium multiplies in the baby's large intestine and creates the toxin. Botulinum toxin causes weakness and loss of muscle tone. It blocks the nerve's ability to signal muscles to contract. It causes a  form of paralysis.​

What are the signs of infant botulism?

• Difficulty feeding (sucking and 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.​

Signs of infant botulism can appear more quickly or may appear up to 30 days after a baby swallows something that contains the bacterium including drinking contaminated formula  Infant botulism is a very rare disease. Not all babies who consume contaminated formula or food will develop infant botulism.

That's why it's important for you and caregivers to watch your baby closely if they used ByHeart formula. Even if the baby seems fine at first, signs of infant botulism could still develop later. 

If you notice any of these signs, contact a doctor right away. 

How does a baby get infant botulism?

Babies get sick when they swallow spores of a particular bacterium, Clostridium botulinum. This bacterium multiplies in the baby's large intestine and creates the toxin. Infants cannot stop the toxin from developing. It is not fully understood why a baby is susceptible. Honey is the one identified and avoidable source of botulinum spores.

Infant Botulism Outbreak FAQs

Can I return the recalled formula for a refund? 

If you bought ByHeart infant formula, you may be able to get a refund. Orders placed on ByHeart.com on or after August 1, 2025, will be eligible for a full refund. If you purchased ByHeart through a retail partner or on Amazon, please contact the retailer directly for their refund process.

You can reach ByHeart by: 

Phone: (866)-201-9069  available 24/7 

Email: hello@byheart.com 

For more information visit byheart.com. ​

What should I do if my baby consumed ByHeart formula? 

Stop using the formula right away. Do not feed your baby any more of it. This includes both cans and single-serve packets. 

• Keep the leftover formula in its original container with the lid on it in a safe place for at least one month. Mark it as "do not use."
• Take a picture of the lot number and expiration date from the container. 
  
• Watch your baby closely for signs of infant botulism. These can develop very quickly or may take up to 30 days to appear. Review signs of infant botulism below. 
  
• Poor feeding (sucking and swallowing)
  
• A weak cry
• 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.

• If your ba​by shows these signs, call your doctor right away. Public health officials may ask to test the leftover formula. 
• If your baby stays healthy for 30 days, you can throw the formula away. 
  

Be sure to wash anything that touched the formula with hot, soapy water or in the dishwasher. Items such as bottles, scoops, or counters. 

What if my baby consumed the formula weeks ago? 

Even if you used the recalled ByHeart formula weeks ago, there is still a chance that signs could appear. Signs of infant botulism can develop very quickly or may take up to 30 days after a baby drinks contaminated formula. 

It's still important to watch closely for signs of infant botulism. Review signs of infant botulism. 

• Difficulty feeding (sucking and 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.

If you notice these signs, contact your doctor right away. Early treatment can help your baby recover more quickly. 

What should I do with bottles, nipples, equipment, etc.? 

If you used the recalled ByHeart formula, you should wash items that may have touched the formula. This includes all bottles, nipples, and any other items. 

Use hot, soapy water or a dishwasher to clean these items. This helps remove leftover formula and bacteria. It also keeps your baby safe from other possible germs. 

If I have leftover ByHeart formula at home, what should I do with it? 

What to do next depends on whether your baby drank the formula: 

If your baby did drink the formula:  

Stop using the formula right away. Do not feed your baby any more of it. This includes both cans and single-serve packets. 

• Keep the leftover formula in its original container with the lid on it in a safe place for at least one month. Mark it as "do not use."
• Take a picture of the lot number and expiration date from the container. 
• Watch your baby closely for signs of infant botulism. These can develop very quickly or may take up to 30 days to appear. Review signs of infant botulism below. 
• Poor feeding (sucking and swallowing)
• A weak cry
• 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.

• If your ba​by shows these signs, call your doctor right away. Public health officials may ask to test the leftover formula. 
• If your baby stays healthy for 30 days, you can throw the formula away. 
  

If your baby did not drink the formula: Throw it away or return it to the place of purchase for a refund. Do not feed it to your baby. 

• Be sure to wash anything that touched the formula with hot, soapy water or in the dishwasher. 
  

What if I gave the formula to my baby's daycare? 

If you gave the recalled ByHeart formula to your baby's daycare, you should: 

• ​Tell the daycare right away so they can stop using it. 
• Ask them to throw away any leftover formula or return it to the store. 
• Make sure they clean any items that may have touched the formula. Items such as bottles, scoops or counters. ​

Should my baby get checked even if they don't have signs of infant botulism? 

If your baby does not have any signs of infant botulism, doctors will not test or treat for infant botulism. Testing and treatment are only done when a medical provider suspects botulism. 

A thorough physical exam and medical history is needed to diagnose infant botulism. If your baby seems healthy, there is no medical reason to test or treat them. This is true even if they drank the recalled formula. 

However, it's still important to watch your baby closely. Signs can develop very quickly or take up to 30 days to appear. If you notice anything unusual, contact your doctor right away. 

Can I get my baby tested just to be sure? 

No, testing for infant botulism is only done if a doctor suspects it based on the medical history and examination. If your baby is healthy and not showing any signs of illness, doctors will not order testing. ​

What should I do if my baby shows signs of infant botulism? 

• Call your baby's doctor or go to the emergency room immediately. 
• Infant botulism is serious and needs quick medical care. Early treatment can help your baby get better faster. 
• Tell the doctor your baby drank ByHeart formula. 
• This helps the doctor know what to look for and decide the best treatment. 
• It's also important to know that these signs can be caused by other illnesses, not just botulism. That's why it's so important to have your baby checked by a medical provider to find out what's going on. 
  

Can my baby get infant botulism again? 

No. Infants treated with BabyBIG^® will have protection for at least six months. This allows time for elimination of the toxin from the baby. This illness was recognized over 45 years ago, and there are no records of an infant getting sick more than once. 

How is infant botulism treated?

Infant botulism is treated with supportive care. There is special attention to feeding and breathing needs. In the United States, the drug BabyBIG^® is used to shorten hospital stay and reduce complications. BabyBIG^® is botulism antitoxin that is approved by the FDA.

Are there any long-term consequences of infant botulism?

No. It is expected that infants will have a full and complete recovery after treatment. Recovery means the nerve endings are able to signal the muscles to contract. The toxin does not enter the brain. So the baby will have the intelligence, skills, and personality they were born with.

Food Consumption Questions

How does infant botulism differ from foodborne botulism?

• ​Infant botulism: It affects babies under 1 year old. If they swallow botulism spores, then a toxin is created inside the baby's large intestine.
• ​Foodborne botulism: Children and adults get this by eating food that is already toxic.
  

My infant was fed a commercial product containing honey. Should I be worried about infant botulism?

See the American Academy of Pediatrics guidelines about feeding solid foods to infants. Many foods and commercial products contain honey. Plus, the manufacturing processes vary. CDPH is unable to know if the food product contains the bacteria that causes infant botulism.

My infant was fed honey. What should I do?

• See the American Academy of Pediatrics guidelines for feeding solids to infants.
• Although honey may have the bacteria that causes infant botulism, a single feeding is not high risk. Not every jar of honey has botulinum spores in it.
• Avoid feeding honey to infants 12 months of age or younger.
• If, in the next few weeks you think your baby shows signs of infant botulism, reach out to your doctor.

Should I continue to breastfeed when my baby has infant botulism? What if I eat honey?

Yes, it is ok for a breastfeeding mother to eat honey. Botulism is not transmitted by breast milk. Continue breast feeding or the feeding of expressed breast milk even when the baby is ill. Hand washing should be strictly enforced. This is especially important in homes where honey is regularly consumed by caregivers. This will prevent honey on surfaces that may come into contact with the infant's mouth.

Even if a mother was to eat botulism spores in honey, the spores cannot get into her breast milk. Breast milk is not a source of the bacterial spores or the toxin that cause infant botulism.

Breast milk is the optimal nutrition for infants. Mothers should be encouraged to continue breastfeeding through their infant's illness and recovery. Refer to the Prevention section below.

​ How should I handle my baby's diapers during recovery?

Babies will still be getting rid of the toxin and bacteria for weeks to months after the illness begins. So, good handwashing should happen after each diaper change. Dispose of soiled diapers quickly in a secure place where no one else can come into contact with them. Persons with open cuts or wounds on their hands should wear gloves when changing diapers. During this time it is advisable for adults to:

• Limit close contact of the patient with other infants and children.
• Supervise any contact of the patient with other infants and children.

This is to prevent other children from coming into contact with a leaky diaper. ​

How can infant botulism be prevented?

The only known way to prevent infant botulism is to avoid feeding honey to infants 12 months or younger. Breastfeeding may slow the onset of illness if it develops.

How soon after BabyBIG® treatment can my child be immunized?

Immunizations should be delayed until the infant has good to full recovery of muscle strength and tone.

• ​For some vaccines, 6 months must pass since BabyBIG® treatment. This is true for:
• ​measles
• mumps
• rubella
• varicella (chicken pox)
• For some vaccines, there must be sustained return of normal bowel function after BabyBIG® treatment. This is true for vaccines for the rotavirus.​
  

How do I contact other families in my area whose children also had infant botulism?

• ​Call the Infant Botulism Treatment and Prevention Program (IBTPP). You can call collect and ask for help.
• Visit the Infant Botulism Facebook page​. If the link doesn't work, then just search for infant botulism.​