FDA Warns Against Some Baby Formulas Following Customer Complaints of Contamination

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The U.S. Food and Drug Administration (FDA) is urging parents to immediately stop use of certain baby formulas possibly linked to several illnesses and one death. In a Thursday announcement, the FDA confirmed that it, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, is investigating certain powdered infant formulas – including Similac, Alimentum, or EleCare – after receiving multiple consumer complaints of infections stemming from the bacteria Cronobacter sakazakii and the strain Salmonella Newport.

The FDA’s investigation includes four infant illnesses in three states – Minnesota, Ohio, and Texas. Of the complaints received, three infections stemmed from Cronobacter, a bacteria that can cause severe, life-threatening infections or inflammation of the membranes that protect the brain and spine. The fourth complaint was one report of Salmonella Newport infection, a group of bacteria that can cause digestive illness and fever. The FDA said all four cases were hospitalized and one death might be connected to the Cronobacter sakazakii bacteria. 

The infections have been linked to powdered infant formula produced in Abbott Nutrition’s Sturgis, Michigan facility. The FDA is advising that people should avoid using Similac, Alimentum, or EleCare powdered infant formulas if 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. The code is printed on the product packaging near the expiration date, and an image can be found by clicking here. The FDA said that products that do not meet all of the above criteria are not impacted by the notice, and the notice does not include liquid formula products or any metabolic deficiency nutrition formulas.

“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,” Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, said in the release. “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.”

In a separate release, Abbott Nutrition, which issued a voluntary recall of the impacted baby formulas, explained that testing in their Sturgis facility “found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.” Abbott Nutrition added that “no distributed product has tested positive for the presence of either of these bacteria, and we continue to test.” An investigation into the matter is ongoing. Consumers are being urged to immediately stop use of the impacted products.