FDA, CDC, and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, Mich., facility, which were received from September 20, 2021 to January 11, 2022. All cases are reported to have consumed powdered infant formulas produced from the 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 indicates environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.
On February 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 also exported to other countries. Canadian health officials have also issued a recall.
FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the seven- to nine-digit code and expiration date on the bottom of the package. Products are included in the recall if they have all three items below:
- The first two digits of the code are 22 through 37;
- 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 FDA’s website. Parents can also enter their product lot code on the company’s website to check if it is part of the recall. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.