Powdered infant formula made by Abbott Nutrition linked to Cronobacter and Salmonella illnesses.

The US Food and Drug Administration (FDA) is investigating four consumer complaints of infant illnesses linked to products from Abbott Nutrition’s Sturgis, MI facility.

The complaints span a period of time from September 6, 2021 to December 18, 2021, and were reported from Minnesota (1), Ohio (1) and Texas (2).

All four infants were fed powdered infant formula produced in Abbott’s Sturgis facility.

The complaints include three reports of Cronobacter illness and one report of Salmonella Newport illness in infants.

All four infants were hospitalized, and one of the infected infants has died.

The death may not be solely attributable to the Cronobacter infection.

The FDA has been conducting an inspection of the facility and has found Cronobacter in several environmental samples. In addition, the company’s internal records include findings of environmental contamination with Cronobacter.

Company records also document the destruction of finished product due to Cronobacter contamination.

The FDA is advising consumers not to use Similac, Alimentum or EleCare powdered infant formulas if:

  • 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.

At this time, the FDA’s advisory is limited to these specific products.

Abbott Nutrition is working with the FDA to initiate a voluntary recall of these products.

Affected products were distributed across the United States and also were likely exported to other countries.

How serious is Cronobacter?

Cronobacter is a foodborne bacterium that can cause a rare, but serious illness in infants. Newborn infants are especially susceptible.

In 2001, nine infants in the Neonatal Intensive Care Unit of a Tennessee hospital were infected with Cronobacter as a result of being tube-fed a batch of Portagen powdered infant formula manufactured by Mead Johnson. One of the babies died.

According to the FDA’s advisory, 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.

Additional information about Cronobacter can be found on the CDC’s website. A history of Cronobacter infections (including the 2001 outbreak linked to Portagen infant formula) can be found in Chapter One of TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures.


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