HEALTH ADVISORY: Recommendation to Report Cronobacter sakazakii Infections in Infants

February 22, 2022

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (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 09/20/2021 to 01/18/2022. All cases are reported to have consumed powdered infant formula 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. Cases were reported in MN (1), OH (1), and TX (2). All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.

The two Texas cases linked to this investigation include a case of C. sakazakii and a case of Salmonella Newport. Both infants were hospitalized, and no deaths were reported.

On February 17, 2022, Abbott Nutrition initiated a proactive, voluntary recall of powdered formulas, including Similac, Alimentum, and EleCare manufactured in Sturgis, MI. Further information about how to identify potentially affected formulaproducts can be found here.

Cronobacter multi-species complex is a group of gram-negative bacteria that exists in the environment and which can survive in very dry conditions. C. sakazakii rarely causes human illness but can cause infant septicemia and severe meningitis that typically results in long-term neurological consequences or death. Cronobacter is ubiquitous in the environment and has been found in many foods, including powdered infant formula and water. Infants with Cronobacter infection typically present with symptoms and signs of blood stream infection or meningitis. Diagnostic evaluation and treatment should be guided by the clinical presentation.

Healthcare providers and laboratories should report infections with C. sakazakii from infants (< 12 months of age) to their respective local health department or the Texas Department of State Health Services (Phone: 512-776-7676, Fax: 512-776-7616).

Additional information:

Recall: https://www.fda.gov/