Updated May 13, 2022  From September 2021 to January 2022, four Cronobacter illnesses and fatalities were reported among infants who had consumed various kinds of Similac powdered infant formula. The Similac products, along with Alimentum or EleCare products were all produced at Abbott Nutrition’s Sturgis, MI facility. After the U.S. Food and Drug Administration (FDA) advised consumers to avoid the purchase or use of these powdered infant formula products, the company issued a recall.

The recalled Similac, Alimentum or EleCare products have the following identification on the bottom of the can.

  • 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.

 


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What is Cronobacter?

Cronobacter is a bacteria that can live on dry foods. Illnesses are rare but can be deadly for newborns, according to the Centers for Disease Control and Prevention (CDC). That’s because Cronobacter can cause sepsis, meningitis, and necrotizing enterocolitis NEC.

For infants, symptoms of sepsis and meningitis include blotchy skin, a pinprick rash, high fever, shivering, fatigue, rapid breathing/difficulty breathing, unusual grunting sounds, refusal to feed, stiff jerky movements or a very floppy body, irritability, diarrhea, cold hands and feet.

If your infant has these symptoms, seek medical help right away.

Baby Formula Illnesses, Deaths

On February 17, 2022, the FDA announced that along with the CDC it was investigating the illnesses of four infants who consumed products made at Abbott Nutrition’s Sturgis, MI facility.  Illnesses from three states, MN (1), OH (1), TX (2),  were reported from September 16, 2021, to January 5, 2021.

Three of the infants developed Cronobacter sakazakii infections and one of them contracted a Salmonella Newport infection. The infants consumed Similac Sensitive, Similac Pro-total Comfort, or  Similac Advance. The Salmonella illness occurred in Texas. All four babies were hospitalized and Cronobacter may have contributed to a death in one case, according to the FDA.

On February 25, 2022, the CDC announced that the agencies are now investigating additional reports of Cronobacter illnesses among infants who consumed the recalled formula. They are using whole genome sequencing to compare the Cronobacter strain isolated from the sick babies to the Cronobacter the FDA found at Abbott Nutrition’s facility in Sturgis, Michigan.

On February 28, 2022, federal health officials announced that an additional fatality has been added to the outbreak total. The illness totals reported from three states are MN (1), OH (2), TX (2), both fatalities occurred in Ohio. The four infants consumed Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40, according to the CDC.

On March 10, 2022, the CDC announced that there was not enough information available to definitively link the Salmonella Newport illness to the recalled infant formula and that is no longer included in this investigation. The CDC stated that it had confirmed that the Salmonella Newport illness is not linked to an outbreak and that it continues to monitor for Salmonella illnesses linked to infant formula.

On March 11, 2022, the FDA announced that specialty products for infants with special medical needs are also manufactured at Abbott’s plant in Sturgis, MI. With the exception of the single lot of Similac 60/40, these products have been excluded from the recall becasue “the FDA has determined that the risk of not having these specialty products available could significantly worsen underlying medical conditions. For many of these patients, the risk of life-threatening adverse events from restricted access to these critically needed products is likely greater than the risk from consuming products that have been produced at the facility. ”

But, the FDA said, it wanted to let parents and caregivers who use these specialty products to be aware that there may be some risk of Cronobacter contamination in these products and they should discuss the best course of action with their babies’ doctors.

The agency also provided a list of non-specialty products that are included in the recall.

FDA Finds Cronobacter at Abbott Nutrition’s Sturgis, MI Plant

On March 22, 2022, the FDA released the forms from its three most-recent inspections of Abbott’s Sturgis plant. These reports revealed Abbott’s failure to maintain a sanitary manufacturing environment including standing water in the facility, missteps in the company’s internal probe of an infant death, the presence of Cronobacter at the facility and in finished product that the company destroyed, and more.

On March 25, 2022, the CDC announced that it had completed laboratory testing on the Cronobacter isolates from “the two available patient samples.” Results showed that these two isolates did not share the same genetic fingerprint, nor did they closely resemble the fingerprints of the multiple strains of Cronobacter cultured from the environmental swabs taken from Abbott’s plant in Sturgis, MI where the products were made.

On May 13, 2022, the CDC announced that it had closed its investigation as no new illnesses had been reported. The FDA announced that its CORE investigators were turning over the investigation to an Incident Management Group (IMG) that will work on supply chain and food safety issues.

 

Cronobacter meningitis

Food Safety Lawyers with Experience

If your baby developed a Salmonella or Cronobacter infection and you would like a free consultation with an experienced Food Safety lawyer, please contact us. You can reach us by calling 1-888-377-8900, sending a text to 612-261-0856, or by completing the form below. There is no obligation and we don’t get paid unless we win.

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UPDATE This post was updated May 13, 2022 to reflect that the CDC has closed its investigation.

UPDATE This post was updated March 27, 2022, to include information about genetic testing performed on strains isolated from two patients.

UPDATE This post was updated on March 11, 2022, to include the FDA’s announcement that specialty products for babies with special medical needs may be contaminated with Cronobacter but were intentionally not included in the recall. And that the FDA has provided a complete list of non-specialty products included in the recall.

UPDATE This post was updated on March 10, 2022, to reflect the removal of one Salmonella Newport illness from this investigation.

UPDATE This post was updated on February 28, 2022, to reflect an additional fatal illness has been added to the case total.

UPDATE This post was originally published on February 17, 2022, and updated February 25 to include information that the CDC is investigating additional reports of illness and the specific brands of formula the sick babies consumed.