Cronobacter sakazakii, formerly Enterobacter sakazakii, is a germ or pathogenic bacteria that can cause illness, primarily among infants younger than two months old, and those who are born premature, have weakened immune systems, or are of low birthweight. Cronobacter is naturally found in the environment and is particularly good at surviving in low-moisture, dry foods, such as powdered infant formula/milk, herbal teas, and starches. Illnesses of Cronobacter sakazakii have been associated with the consumption of powdered infant formula. While Cronobacter infections are rare, they can be deadly for young infants and for people with weakened immune systems.
Cronobacter can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively. Complications of Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death.
Symptoms related to Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.
How can foods become contaminated by Cronobacter sakazakii?
Cronobacter sakazakii, and its cousins in the broader Cronobacter genus, are part of a large family of bacteria that are common in the environment — like in our yards, kitchens, and living rooms — so identifying the specific source of an illness or outbreak can be challenging. Cronobacter has the potential to come into food facilities, homes, and hospitals on the soles of shoes or on hands and can then live on surfaces like counters, sinks, bottles or other feeding utensils.
Cronobacter infections are most dangerous to infants younger than two months old, and those who are born premature, immunocompromised, or of low birthweight. Individuals of any age group who have weakened immune systems may also be at risk.
Preventing Foodborne Illness at Home
Safely Preparing and Storing Powdered Infant Formula
In most cases, it is safe to mix powdered infant formula following manufacturer’s instructions. If your baby is less than 2 months old, was born prematurely, or has a weakened immune system the Centers for Disease Control and Prevention (CDC) recommends using ready-to-feed infant formula. Liquid infant formula is made to be sterile (without germs) and is the safest option for infants not receiving breast milk. However, you can also take extra steps to prepare powdered formula for these infant groups by heating water to at least 158°F/70°C to help protect against Cronobacter, adding the powdered infant formula, and then cooling the formula to body temperature (98.6°F) before feeding your infant.
However, certain metabolic and specialty products include statements on their packaging warning consumers against heating because heating the particular product above 100°F could result in a loss of vitamins and nutrients. Therefore, caregivers should be especially mindful of the manufacturer’s instructions included on the packaging for specialty metabolic formulas.
Parents who suspect their infant became ill due to infant formula may call the FDA’s consumer hotline at 1-800-FDA-1088.
See additional information from FDA and CDC on safe formula preparation:
- Help Prevent Cronobacter Illness: Prepare and Store Powdered Infant Formula Safely (FDA)
- Protect your baby from Cronobacter (CDC)
Other Tips to Minimize the Risk of Cronobacter Contamination
Infants could also be exposed to Cronobacter from unclean breast pumps or unclean bottles. To help keep your baby safe, you can help prevent Cronobacter from growing on these items.
- Keep your baby’s food, whether breast milk or formula, safe by carefully cleaning, sanitizing, and storing bottles and breast pump parts.
- Wash your hands with soap and water for at least 20 seconds, especially before preparing bottles and feeding. If soap and water are unavailable, the CDC recommends using an alcohol-based hand sanitizer with at least 60% alcohol.
- Clean countertops and any work surfaces that come into contact with formula, bottles, or breast pump parts soap and water, or other disinfectant.
Who to Contact
To report a complaint or adverse event (illness or serious allergic reaction), you can:
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Visit www.fda.gov/fcic for additional consumer and industry assistance.
- What to Know About Cronobacter sakazakii
- Prevention Strategies to Enhance Food Safety
- Cronobacter Infection and Infants | CDC
- NCBI taxonomy database
- World Health Organization Cronobacter Information
- CDC Cronobacter Information
- CDC Graphic: How to Prepare and Store Powdered Infant Formula