Senators Question Abbott About Delay in Recalling Potentially Contaminated Infant Formulas

On February 17, 2022, baby formula-maker Abbott Nutrition announced a recall of certain powder formulas—including Similac, Alimentum, and EleCare. The recall included only those products that were made at the manufacturer’s Sturgis, Michigan facility, as these were linked to complaints of bacterial infections in infants.

Two U.S. senators are now asking why Abbott waited as long as it did to recall these formulas, particularly since it received warnings about potential contamination problems as far back as September 2021.

On February 24, 2022, senators Patty Murray—chair of the U.S. Senate Committee on Health, Education, Labor and Pensions—and Robert P. Casey, Jr.—chair of the Subcommittee on Children and Families—sent a letter to Abbott CEO Robert B. Ford expressing concern about the timing of the recall, and demanding answers.

FDA and CDC Investigating Reports of Infant Illness Connected to Abbott Powdered Formulas

On the same day that Abbott initiated the recall, the U.S. Food and Drug Administration (FDA) announced that it was investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections:

“All of the cases are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, Michigan facility,” the FDA stated. The agency, along with the U.S. Centers for Disease Control and Prevention (CDC) warned consumers to avoid purchasing or using powdered infant formula made at the Sturgis facility.

On February 28, 2022, the FDA released an update, notifying the public of one additional illness connected to the formula, noting that a cronobacter infection “may have been a contributing cause of death for this patient.” In total, the FDA and CDC are investigating five reports of infections in infants related to Abbott Nutrition’s powdered formula products.

Why Did Abbott Wait So Long to Recall Its Potentially Contaminated Products?

In their letter to the Abbott CEO, the U.S. Senators noted that while the Abbott recall was a “critical step to ensuring additional children do not become sickened by these products,” they were “incredibly concerned that the company received complaints as early as September 2021 but only took public action last week.”

The Senators went on to state that it is “completely unacceptable” that Abbott’s manufacturing conditions allowed a contaminated product to reach babies, and that “it took months for the company to act to warn parents and caregivers about this danger. We demand answers.”

The senators aren’t the only ones. Abbott is also facing at least two class-action lawsuits filed by parents who have the same question: Why did Abbott wait so long to act?

The Minnesota Department of Health began investigating a case of an infant infected with Cronobacter sakazakii in September 2021. The baby was hospitalized for 22 days. The investigation revealed that the baby had been fed with formula produced at Abbott’s Sturgis facility. Two more reports of Cronobacter sakazakii infections came in between September and December, as well as one report of a Salmonella Newport illness. The fifth illness was only recently reported.

The FDA initiated an inspection of the facility on January 31, 2022, a spokesperson told POLITICO. Inspectors found Cronobacter sakazakii in several environmental samples taken at the plant. They also found records “suggesting the company had been finding the bacteria in the plant and had destroyed product because of the issue.”

Cronobacter sakazakii is a rare but serious foodborne pathogen that can cause severe, sometimes life-threatening infections. Salmonella Newport is also an antibiotic-resistant infection that can cause severe intestinal illness.