February 23, 2022 | Susan Napier-Sewell

FDA Warning: Powdered Baby Formulas Potential Cause of Cases, 1 Death

powdered baby formula

The FDA has issued a warning against specific powdered baby formulas, and an investigation is underway.

The U.S. Food and Drug Administration is currently issuing a warning against some powdered baby formulas. The FDA is investigating the products following reports of babies contracting serious infections, with one death being reported.

The FDA announced it is 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.

As a result of the ongoing investigation into the powdered baby formulas, along with the U.S. Centers for Disease Control and Prevention and state and local partners, the FDA is alerting consumers to avoid purchasing or using certain powdered infant formulas produced at this facility.

This is an ongoing investigation, and the firm is working with the FDA to initiate a voluntary recall of the potentially affected product. 

Specific baby formulas in the FDA warning are Similac, Alimentum, EleCare.

What to look for on powdered baby formulas under investigation:

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas 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.

The FDA is investigating complaints of four infant illnesses from three states. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case. The FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter

“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible.”

Source: U.S. Food & Drug Administration, “FDA Warns Consumers Not to Use Certain Powdered Infant Formula Produced in Abbott Nutrition’s Facility in Sturgis, Michigan,” Feb. 17, 2022.

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Current Events, Investigations, Safety
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