Category Archives: Cronobacter sakazakii

USA – DOJ Starts Criminal Investigation into Abbott Over Formula – Cronobacter

Food Poisoning Bulletin

According to news reports, the Department of Justice has started a criminal investigation into Abbott Laboratories in relation to the cronobacter contamination at the Abbott plant that caused a shutdown last year and the resulting baby food supply crisis that triggered a severe shortage of powdered baby formula. Cronobacter can cause serious illness in infants and can be deadly.

Research – A Comprehensive Review of Variability in The Thermal Resistance (D-Values) of Food-Borne Pathogens—A Challenge for Thermal Validation Trials



The thermal processing of food relies heavily on determining the right time and temperature regime required to inactivate bacterial contaminants to an acceptable limit. To design a thermal processing regime with an accurate time and temperature combination, the D-values of targeted microorganisms are either referred to or estimated. The D-value is the time required at a given temperature to reduce the bacterial population by 90%. The D-value can vary depending on various factors such as the food matrix, the bacterial strain, and the conditions it has previously been exposed to; the intrinsic properties of the food (moisture, water activity, fat content, and pH); the method used to expose the microorganism to the thermal treatment either at the laboratory or commercial scale; the approach used to estimate the number of survivors; and the statistical model used for the analysis of the data. This review focused on Bacillus cereus, Cronobacter sakazakii, Escherichia coli, Listeria monocytogenes, and Clostridium perfringens owing to their pathogenicity and the availability of publications on their thermal resistance. The literature indicates a significant variation in D-values reported for the same strain, and it is concluded that when designing thermal processing regimes, the impact of multiple factors on the D-values of a specific microorganism needs to be considered. Further, owing to the complexity of the interactions involved, the effectiveness of regimes derived laboratory data must be confirmed within industrial food processing settings.


USA – FDA Core Investigation Table -Investigations of Foodborne Illness Outbreaks


What’s New

  • While FDA’s overall response regarding powdered infant formula is continuing, this investigation of Cronobacter illnesses linked to powdered infant formula (reference #1056) has been marked as closed. Resources for Parents and Caregivers are available on the FDA website and additional updates will be provided as needed.
  • The outbreak of Salmonella Litchfield linked to seafood (reference #1105) is over and the FDA investigation has closed. 
  • The outbreak of Listeria monocytogenes linked to Brie and Camembert Cheese (reference #1106) is over and the FDA investigation has closed. 
  • The case count for the outbreak of Salmonella Typhimurium has increased from 270 to 274 cases.

USA – Byheart Issues Voluntary Recall of Five Batches of Its Infant Formula Because of Possible Health Risk – Cronobacter sakazakii


Product image front can label ByHeart Whole Nutrition Infant Formula Milk-Based Powder with Iron for 0-12 Months, NET WT 24 OZ (680g)”

Product image side can label ByHeart Whole Nutrition Infant Formula Milk-Based Powder with Iron for 0-12 Months, NET WT 24 OZ (680g)


Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Reason for Announcement:
Potential for cross-contamination with Cronobacter sakazakii
Company Name:
Brand Name:
Product Description:
Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12months

Company Announcement

None of the distributed ByHeart product has tested positive for any contaminants

No consumer complaints received, to date, that would indicate any illness

Recall is not related to ByHeart’s own manufacturing facility in Reading, PA in any way; facility continues to run 24/7; re-stock expected in January

ByHeartExternal Link Disclaimer, a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall five batches of ByHeart Whole Nutrition Infant Formula due to the potential for cross-contamination with Cronobacter sakazakii. No distributed ByHeart product has tested positive for the bacteria.

The product being recalled is ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24 oz containers. The formula under voluntary recall was distributed directly to consumers in the U.S. and can be identified by the number on the bottom of the can. Recalled product batches are 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 printed with use by 01 JAN 24 or 01JUL 24.

Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

It is important to note that this recall is not related to ByHeart’s own manufacturing in any way. In addition, the company has not received any consumer complaints that would indicate any illness, to date; illness complaints are an early detection of safety concerns. If a baby has already consumed all of the formula, there is no reason for concern, and no additional action is needed. If parents have any questions, they should consult with their pediatrician.

ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is conducted by a reputable third-party packager. ByHeart is taking this precautionary measure because one test sample collected from the third-party packaging facility tested positive for Cronobacter sakazakii. All product packaged that day, and the first production on the next day, was isolated for destruction and not distributed. Out of an abundance of caution, we are now recalling all product produced during the entire production run.

As a company committed to parents, ByHeart holds itself to the highest standards when it comes to safety and applauds the FDA’s efforts to oversee the safe manufacturing of infant formula. Parents can remain confident in the safety of ByHeart’s products as the company continues to expand its investments in infant formula innovation, clinical studies, and industry-leading quality standards. ByHeart’s manufacturing facility in Reading, PA, continues to operate 24/7, and the company is committed to providing customers formula in January.

What ByHeart Customers Should Do

Customers who purchased ByHeart product should check the bottom of the can and dispose of product from batches 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1. ByHeart is setting up a webpage at Link Disclaimer with additional information about its measures. Should customers have any other questions or want to find out if the product they have is included in the voluntary recall, please email or text ByHeart at 1-909-506-2354. The company will also be reaching out directly to all customers via email who purchased orders from these identified batches.

ByHeart knows that formula is critical to a baby’s health and growth and wants to make sure that all customers have what they need to keep their baby fed and healthy, no matter what brand of formula they use. While ByHeart works 24/7 to meet the demand for formula, the fastest way the company can replace the formula customers purchased is to cover the cost of two cans of alternate formula. Additionally, affected customers will receive two cans of their next order of ByHeart Whole Nutrition Formula for free.

If your infant is experiencing symptoms related to Cronobacter infection, contact your health care provider to report their symptoms and receive immediate care. To report an illness or adverse event, you can


Company Contact Information


Research – Inhibition of Cronobacter sakazakii by Litsea cubeba Essential Oil and the Antibacterial Mechanism



Litsea cubeba essential oil (LC-EO) has anti-insecticidal, antioxidant, and anticancer proper-ties; however, its antimicrobial activity toward Cronobacter sakazakii has not yet been researched extensively. The objective of this study was to investigate the antimicrobial and antibiofilm effects of LC-EO toward C. sakazakii, along with the underlying mechanisms. The minimum inhibitory concentrations of LC-EO toward eight different C. sakazakii strains ranged from 1.5 to 4.0 μL/mL, and LC-EO exposure showed a longer lag phase and lower specific growth compared to untreated bacteria. LC-EO increased reactive oxygen species production, decreased the integrity of the cell membrane, caused cell membrane depolarization, and decreased the ATP concentration in the cell, showing that LC-EO caused cellular damage associated with membrane permeability. LC-EO induced morphological changes in the cells. LC-EO inhibited C. sakazakii in reconstituted infant milk formula at 50 °C, and showed effective inactivation of C. sakazakii biofilms on stainless steel surfaces. Confocal laser scanning and attenuated total reflection–Fourier-transform infrared spectrometry indicated that the biofilms were disrupted by LC-EO. These findings suggest a potential for applying LC-EO in the prevention and control of C. sakazakii in the dairy industry as a natural antimicrobial and antibiofilm agent.

Slovakia – Cronobacter prompts infant formula recall in Slovakia

Food Safety News

A brand of infant formula has been recalled in Slovakia because of Cronobacter sakazakii contamination.

The Public Health Authority of the Slovak Republic (UVZSR) said the issue was detected as part of official food controls by authorities. No related illnesses have been reported.

The affected goat’s milk infant formula was made in the Czech Republic by Goldim. The product is “Naše mléko 1” with a date of Oct. 31, 2023, and lot number L430. It is intended for infants up to 6 months of age.

The product was analyzed in an accredited regional public health authority (RÚVZ) laboratory and it did not comply with the microbiological legislation for Cronobacter sakazakii.

UVZSR said this means the formula is considered not to be safe and should be withdrawn from the market.

RASFF Alert – Cronobacter – Infant Formula


Cronobacter in infant formula from Czech Republic in Slovenia

Research – Another drop in outbreaks was recorded in Germany for 2021

Food Safety News

The amount of foodborne outbreaks reported in Germany has continued to fall, according to the latest figures.

In 2021, the Robert Koch-Institut (RKI) and Federal Office of Consumer Protection and Food Safety (BVL) received slightly fewer reports of outbreaks with 168 compared to 193 in the previous year.

At least 1,179 cases, 196 hospitalizations, and two deaths were related to them in 2021. As in previous years, the top causes were Campylobacter and Salmonella.

Other agents involved in outbreaks were norovirus, Bacillus cereus, hepatitis A virus, Listeria monocytogenes, Clostridium perfringens, Yersinia enterocolitica, Shiga toxin-producing E. coli (STEC), Clostridium botulinum, Cronobacter sakazakii, histamine, Shigella, and Staphylococcus aureus. In seven outbreaks with 73 cases, the pathogen remained unknown.

Nineteen of the 22 outbreaks with more than five patients were caused by Salmonella.

Research – What to Know About the Risk of Cronobacter in Powdered Infant Formula


The U.S. Food and Drug Administration continues to help ensure the safety of powdered infant formula in the wake of reports of Cronobacter sakazakii infections in four infants that may have contributed to death in two patients.

Those reports led to an FDA investigation of Abbott Nutrition in Sturgis, Michigan. Insanitary conditions found at the facility led to the February 2022 voluntary recall of specific lots of powdered infant formula manufactured at the facility and brought attention to a type of bacteria that many parents may not have heard about before and scientists continue to work to better understand.

While Cronobacter contamination and infections are rare, it is still important to know the risks and what you can do to minimize them.

What Is Cronobacter?

Cronobacter is a germ (bacteria) that is naturally found in the environment. Cronobacter can exist on almost any surface and is especially good at surviving in dry foods, like powdered infant formula, powdered milk, herbal teas, and starches.

Cronobacter is harmless for most people and infections are rare. When they do occur, they can be life threatening in infants, particularly those who are younger than two months old, premature, immunocompromised, or of low birthweight.

How Does Powdered Infant Formula Become Contaminated with Cronobacter?

Parents may not know that while powdered infant formula manufacturers are required to produce formula that is safe from harmful bacteria like Cronobacter, powdered formulas — unlike liquid formulas — do not receive certain processing treatments that would render them sterile.

Cronobacter has the potential to come into factories, homes, and hospitals on the soles of shoes or on hands and can then live on surfaces like counters or bottles.

At the factory, Cronobacter could get into formula powder if:

  • Contaminated ingredients are used to make the formula.
  • The formula powder touches a contaminated surface.

In the home, infants can get infected by Cronobacter through multiple pathways including:

  • Inadequately sanitized breast-pump accessories, bottles, and other utensils used for feeding.
  • Inadequate handwashing prior to infant formula preparation.
  • Formula lids or scoops placed on contaminated surfaces, like countertops or sinks, that then later touch the formula.
  • Contaminated water used to mix formula.

Why Is it Difficult to Find the Source of Cronobacter Contamination?

Cronobacter sakazakii and its cousins in the broader Cronobacter species category 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.

Importantly, only one state in the U.S., Minnesota, currently requires that cases of Cronobacter sakazakii be reported to state public health authorities. As a result, many cases are unreported, and scientists have limited information about the genetic makeup of the bacteria found in cases that are reported. To provide some perspective, the National Center for Biotechnology Informatics (NCBI) database that tracks these pathogens has received roughly 480,000 submissions of genomic information for strains of Salmonella enterica compared to only 1086 submissions for strains of Cronobacter.

What Can You Do to Minimize the Risk of Cronobacter Contamination?

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 using hot water (at least 158°F/70°C) to help protect against Cronobacter and then cooling the formula 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. If the instructions prevent a consumer from heating their formula to at least 158°F, then caregivers should instead bring the water used to mix the formula to body temperature and follow the instructions in this printable infographic to prepare and store powdered infant formula safely.

Parents who suspect their infant became ill due to infant formula may call the FDA’s consumer hotline at 1-800-FDA-1088.

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.

It is also important to wash your hands with soap and water, especially before preparing bottles and feeding. The CDC says that alcohol-based hand sanitizer with at least 60% alcohol can also be used.

What Are the Symptoms of Cronobacter infection?

Symptoms of infection in infants may start with fever, poor feeding, excessive crying, and/or very low energy. Some infants may also have seizures. Babies with these symptoms should be taken to a medical provider as soon as possible.

Canada – 4 In. Split Top Brioche Style Buns recalled due to potential presence of dangerous bacteria and Cronobacter sakazakii



4 In. Split Top Brioche Style Bun
Food – Microbial Contamination – Clostridium botulinum
Food – Microbial Contamination – Other
What to do

Do not use, sell, serve or distribute the affected product.

Hotels, restaurants and institutions

Affected products


No brand 4 In. Split Top Brioche Style Buns recalled due to potential presence of Clostridium botulinum and Cronobacter sakazakii.

The recalled product has been sold in Ontario.