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In this section: Outbreaks of Foodborne Illness
 * Outbreaks of Foodborne Illness
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 1. Home
 2. Food
 3. Recalls, Outbreaks & Emergencies
 4. Outbreaks of Foodborne Illness
 5. FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant
    Formula (February 2022)

 1. Outbreaks of Foodborne Illness


FDA INVESTIGATION OF CRONOBACTER AND SALMONELLA COMPLAINTS: POWDERED INFANT
FORMULA (FEBRUARY 2022)

Do not use recalled Similac, Alimentum, or EleCare powdered infant formulas

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If you want to check if your powdered formula is part of the recall, you can
enter the product lot code on the bottom of your package on the company’s
websiteExternal Link Disclaimer.

If you have questions or need information about the recall, you can Submit
Questions/Get Assistance. 

If your infant is experiencing symptoms related to Cronobacter or Salmonella
infection, such as poor feeding, irritability, temperature changes, jaundice,
grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or
stool; contact your health care provider to report their symptoms and receive
immediate care.

To report an illness or adverse event, 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.

The FDA, along with CDC and state and local partners are investigating four
consumer complaints of infant illness related to products from Abbott
Nutrition’s Sturgis, MI facility received from 9/20/2021 to 1/11/2022. All of
the cases are reported to have consumed powdered infant formula (IF) produced
from Abbott Nutrition’s Sturgis, MI facility. These complaints include three
reports of Cronobacter sakazakii infections and one report of Salmonella Newport
infection in infants. All four cases related to these complaints were
hospitalized and Cronobacter may have contributed to a death in one case.

FDA has initiated an onsite inspection at the facility. Findings to date include
several positive Cronobacter results from environmental samples taken by FDA,
and adverse inspectional observations by FDA investigators. A review of the
firm’s internal records also indicate environmental contamination with
Cronobacter sakazakii and the firm’s destruction of product due to the presence
of Cronobacter.

FDA is issuing this advisory to alert consumers to avoid purchasing or using
recalled powdered infant formula produced in the Sturgis, MI facility.

On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered
infant formulas. Products made at the Sturgis facility can be found across the
United States and were likely exported to other countries as well. Canadian
health officials have also issued a recall warningExternal Link Disclaimer. FDA
is continuing to investigate and will update this advisory should additional
consumer safety information become available.


RECOMMENDATION 

The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare
powdered infant formulas. Recalled products can be identified by the 7 to 9
digit code and expiration date on the bottom of the package (see image below).
Products are included in the recall if they have all three items below:

 * the first two digits of the code are 22 through 37 and
 * the code on the container contains K8, SH, or Z2, and
 * the expiration date is 4-1-2022 (APR 2022) or later.

Additional recall information is available on the FDA website. Parents can also
enter their product lot code on the company’s websiteExternal Link Disclaimer to
check if it is part of the recall.

Additional Information for Parents and Caregivers:

The recall does not include liquid formula products or any metabolic deficiency
nutrition formulas. Consumers should continue to use all product not included in
the recall.

Parents and caregivers should never dilute infant formula and should not make or
feed homemade infant formula to infants. Consumers should also avoid purchasing
imported formula through online sales, as it has the potential to be
counterfeit.

If your regular formula is not available, contact your child’s healthcare
provider for recommendations on changing feeding practices. 

More information on Cronobacter and infant formula is available on CDC’s
website.

Recalled powdered infant formulas have the potential to be contaminated with
Cronobacter, a bacterium that can cause severe foodborne illness primarily in
infants. Cronobacter infections are rare but are especially high risk for
newborn infants (see symptoms below).

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.

If your child is experiencing any of these symptoms, you should notify your
child’s healthcare provider and seek medical care for your child immediately.
Healthcare providers and health departments are encouraged to report any
confirmed cases of Cronobacter sakazakii to CDC.

--------------------------------------------------------------------------------


PRODUCT IMAGES





--------------------------------------------------------------------------------


CASE COUNTS

Total Adverse Events: 4 (3 Cronobacter, 1 Salmonella)
Hospitalizations: 4
Reported Deaths: 1*
Adverse Event Dates: 9/6/2021 – 12/18/2021
States with Adverse Events: MN (1), OH (1), TX (2)
Product Distribution: Nationwide and International
*One death has been reported but has not been confirmed to be solely
attributable to Cronobacter infection. 


USEFUL LINKS

 * U.S. Recall Announcement
 * Canadian Recall WarningExternal Link Disclaimer
 * Abbott Nutrition Recall SiteExternal Link Disclaimer
 * Cronobacter Infection and Infants (CDC)
 * What is Salmonella?
 * Food Safety Tips for Consumers & Retailers During an Outbreak
 * Who to Contact

--------------------------------------------------------------------------------


INTERNATIONAL PRODUCT DISTRIBUTION

According to the firm, recalled products were distributed to the following
countries: Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China,
Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong
Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New
Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa,
Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI
South.


PREVIOUS UPDATES

2/17/2022

The FDA, along with CDC and state and local partners are investigating four
consumer complaints of infant illness related to products from Abbott
Nutrition’s Sturgis, MI facility received from 9/6/2021 to 12/18/2021. All of
the cases are reported to have consumed powdered infant formula (IF) produced
from Abbott Nutrition’s Sturgis, MI facility. These complaints include three
reports of Cronobacter sakazakii infections and one report of Salmonella Newport
infection in infants. All four cases related to these complaints were
hospitalized and Cronobacter may have contributed to a death in one case.

FDA has initiated an onsite inspection at the facility. Findings to date include
several positive Cronobacter results from environmental samples taken by FDA,
and adverse inspectional observations by FDA investigators. A review of the
firm’s internal records also indicate environmental contamination with
Cronobacter sakazakii and the firm’s destruction of product due to the presence
of Cronobacter.
FDA is issuing this advisory to alert consumers to avoid purchasing or using
certain powdered infant formula produced in the Sturgis, MI facility.

This is an ongoing investigation and the firm is working with the FDA to
initiate a voluntary recall of potentially affected product.  FDA is continuing
to investigate and will update this advisory should additional consumer safety
information become available.

--------------------------------------------------------------------------------


WHO TO CONTACT

If you want to check if your powdered formula is part of the recall, you can
enter the product lot code on the bottom of your package on the company’s
websiteExternal Link Disclaimer.

If you have questions or need information about the recall, you can Submit
Questions/Get Assistance. 

If your infant is experiencing symptoms related to Cronobacter or Salmonella
infection, such as poor feeding, irritability, temperature changes, jaundice,
grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or
stool; contact your health care provider to report their symptoms and receive
immediate care.

To report an illness or adverse event, 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.

Follow Us on TwitterExternal Link Disclaimer


   CONTENT CURRENT AS OF:
   
   02/20/2022


 * REGULATED PRODUCT(S)
   
    * Food & Beverages

 * Outbreaks of Foodborne Illness
    * Investigations of Foodborne Illness Outbreaks
    * Public Health Advisories from Investigations of Foodborne Illness
      Outbreaks
    * Food Safety Tips for Consumers & Retailers During an Outbreak of Foodborne
      Illness
    * Food Safety Resources for Produce Shippers and Carriers During a Foodborne
      Illness Outbreak
    * Environmental Assessments from Foodborne Illness or Contamination Events
    * How to Report Seafood-Related Toxin and Scombrotoxin Fish Poisoning
      Illnesses
    * About the CORE Network
   
    * Foodborne Pathogens


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