Cronobacter sakazakii United States · 2021 to 2022

Cronobacter infections and powdered infant formula from Abbott Nutrition, Sturgis, United States, 2022

FDA investigated four reports of Cronobacter illness in infants in Minnesota, Ohio and Texas who consumed powdered formula from the Abbott Nutrition facility in Sturgis, Michigan. All four were hospitalised and FDA said Cronobacter may have contributed to the deaths of two. FDA found Cronobacter sakazakii in five environmental samples at the plant, but CDC whole genome sequencing found the two available clinical samples were not a genetic match to the environmental strains. Abbott recalled products in February 2022 and a federal court entered a consent decree in May 2022.¹

Counts as reported on 1 August 2022.¹ Food vehicle: Powdered infant formula produced at the Abbott Nutrition facility in Sturgis, Michigan. Company named in official findings: Abbott Nutrition (Sturgis, Michigan facility).

Timeline

1. 6 September 2021Earliest illness onset among the four cases.¹
2. 31 January 2022FDA inspection of the Sturgis facility began.¹
3. 17 February 2022Abbott initiated a voluntary recall.¹
4. 28 February 2022Abbott recalled a lot of Similac PM 60/40.¹
5. 18 March 2022FDA issued a Form 483 with four observations.¹

Regulatory and legal outcomes

1. 16 May 2022US District Court, Western District of Michigan. Entered a consent decree of permanent injunction between FDA and Abbott Nutrition.¹

Sources

1. US Food and Drug Administration, FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022) (1 August 2022)