Infant Botulism

Current Outbreak of Infant Botulism, August-November 2025

An outbreak of infant botulism has occurred in the U.S. in multiple states in some infants who have been fed ByHeart infant formula.
Cases have been identified in Illinois babies as well as infants in multiple other states.

Infant botulism is a rare disease. Just because you have fed your baby this formula does not mean your baby will get infant botulism.
Infant botulism can occur from 3 days to 30 days after the last time the infant was fed formula.
Parents should monitor for symptoms in their baby for 30 days after the last use of the product. These symptoms can include drooping eyelids, weak or altered cry, poor feeding, loss of head control, decreased facial expression, and difficulty swallowing. If a baby develops these type of symptoms the parent should call the baby’s health care provider immediately. If the provider is not available, then the baby should be taken to the emergency department.
If you have leftover ByHeart infant formula that your infant was fed, keep it stored for 30 days if you can do this safely. Please mark the infant formula with “DO NOT USE” so no one in the household uses it for the baby, and put it on a high shelf in your kitchen. If you cannot store it safely and there is a risk of it being mistakenly fed to an infant, dispose of it in the trash.
Please take a photo of the information on the product including lot number.
If your infant develops symptoms of botulism, your local health department may want to collect it for testing. If no symptoms appear after 30 days, throw the leftover formula away with the “DO NOT USE” note on the container.
Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.

Infant botulism is a rare but serious disease. Symptoms can include difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.
Infant botulism happens when infants swallow spores from the bacteria Clostridium botulinum that grow in the baby’s intestinal tract and make a toxin that causes symptoms in the baby.
This bacteria can be found in honey, the environment and occasionally in infant formula. Infants should never be fed honey.
Infant botulism can be treated with a special medication called BabyBIG. A health care provider must consult with the infant botulism program in California in order to have the medication approved and made available.
Botulism cannot be spread from one infant to another infant.
There is no vaccine available for botulism.

Laboratories in the state may be asked about laboratory testing for infant botulism.
Testing will only be performed on babies for whom the California Infant Botulism Treatment and Prevention Program has approved BabyBIG treatment.
Botulism testing is very complex and rule out testing cannot be done on babies who have not been approved for BabyBIG treatment.
For babies who have been approved for BabyBIG administration and testing is needed, please call your local health department for information on specimen collection methods for botulism.
The specimens should be shipped to an IDPH laboratory.
Botulism cases are required to be immediately reported to the local health department.

Local health departments (LHDs) may receive calls from health care providers or parents about infant botulism. CDC and FDA have websites dedicated to this situation to keep up to date on this outbreak. LHDs can also confer with IDPH Communicable Disease staff with any questions.
Local health departments may be asked to assist with audit checks on the infant formula recall.
Local health departments should call IDPH about any suspect cases and enter information about the case in INEDSS.
IDPH will alert local health departments about any suspect cases in their jurisdiction.

Health care providers who see infants may get questions about this infant botulism outbreak so they should keep up-to-date on the outbreak by reviewing IDPH, CDC and FDA information. There will be SIREN messaging and website information available for use.
All lots of ByHeart formula have been recalled.
Infants can get botulism from 3 to 30 days after they are exposed to the organism.
Signs and symptoms include constipation, poor feeding, loss of head control, and difficulty swallowing which can lead to difficulty breathing.
If health care providers see a baby with symptoms consistent with botulism they can call the California Infant Botulism Treatment and Prevention Program for approval to receive BabyBIG treatment for the infant. They should also report any suspect cases to their local health department.
Only infants who are approved for BabyBIG treatment can be tested for infant botulism.
Botulism testing is complicated and only to be used with persons approved for BabyBIG or adults approved for anti-toxin use. There is no simple rule out test for botulism. Treatment should not be withheld pending testing results if botulism is suspected and treatment is approved.