FDA Provides Further Warnings after Second Infant Death, Abbott Expands Recall

On February 28th, the U.S. Food and Drug Administration (FDA) posted an updated warning on certain Abbott powdered baby formula products that have been found to contain Cronobacter and Salmonella. 

The updated warning and recall includes a powdered baby formula meant for infants that benefit from lowered mineral intake. 

The FDA warning advises parents and caretakers not to feed infants certain powdered baby formulas produced by Abbott. 

Bacterial infections from Abbott powdered baby formula products have led to the hospitalization of five infants and the death of two. These infections were caused by Cronobacter and Salmonella contamination in the Sturgis, Michigan Abbott plant. 

Abbott has voluntarily recalled the powdered formula products at the root of the FDA investigation and is facing class action complaints in Illinois and Florida.

The expanded recall of products stems from the hospitalization and death of an infant who consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800. The infant was diagnosed with a Cronobacter infection. 

Products included in the original recall are certain lots of Similac, Alimentum, and EleCare.

The FDA warning advises against the consumption of products 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.

Similac, Enfamil, and other cow milk-based baby formulas have been linked to necrotizing enterocolitis (NEC), a gastrointestinal disease that primarily affects premature babies. The symptoms and effects of NEC can range from mild to fatal.

The marketing of these products and absence of warnings have triggered lawsuits to be filed in a number of states.