Baby formula that may be linked to 1 death, other hospitalizations prompts FDA warning

The U.S. Food and Drug Administration says it started an investigation after several infants contracted infections after consuming powdered baby formula from Abbott’s Nutrition Sturgis, Michigan facility.

The FDA says four complaints were raised by consumers between September and December 2021 spanning Minnesota, Ohio and Texas.

“These complaints include three reports of cronobacter sakazakii infections and one report of salmonella newport infection in infants,” according to the FDA investigation announced in a Feb. 17 news release. “All four cases related to these complaints were hospitalized and cronobacter may have contributed to a death in one case.”

The FDA is now “advising consumers not to use Similar, Alimentum or EleCare powdered instant 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.”

Parents and caregivers can find that information on the product packaging near the expiration date, FDA says.

“We value the trust parents place in us for high quality and safe nutrition and we’ll do whatever it takes to keep that trust and resolve this situation,” Abbott told McClatchy News in a statement.

On Feb. 17, Abbott announced it initiated a voluntary recall of their powder formulas with an expiration of April 1, 2022, or later, manufactured in Sturgis, Michigan.

“No Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall,” Abbott says in a news release.

Products made at the Sturgis facility were distributed across the United States, the FDA says, and may have been exported to other countries.

According to the CDC, cronobacter is a bacteria found in dry foods which can cause severe meningitis and in some cases seizures. Though cronobacter infections are rare, “the mortality rate for cronobacter meningitis may be as high as 40%,” the CDC says.

Symptoms for salmonella infections include “diarrhea, fever, and stomach cramps,” according to the CDC. While most people recover without treatment, children under the age of 5 are “more likely to have a severe illness,” CDC says.

The FDA says it has begun inspecting the Michigan facility and reports finding samples of cronobacter as well as “adverse inspectional observations.”

Abbott says the company conducts routine testing for the bacteria and admits finding evidence of cronobacter in “non-product conduct areas,” but said it found no salmonella.

“Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test,” the company said in a release.

The FDA recommends parents contact their childcare providers if they notice any symptoms. While this is still an ongoing investigation, the agency says it will share any new consumer safety information as it arises.

“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 a news release.

This voluntary baby formula recall comes as the U.S. has been experiencing a shortage of infant powdered formula.

Empty shelves have been linked to a mix of staff shortages, a lack of certain ingredients to make the formula, and supply chain issues, The New York Times reported.

The Infant Nutrition Council of America told CBS that “there are reports of challenges across retail supply chains, from transportation and logistics to some anecdotal evidence suggesting pantry-loading behaviors.”

The average national in-stock rate for baby formula has plummeted from 95% before the coronavirus pandemic to as low as 75% across national retailers earlier this year, Krishnakumar “KK” Davey, the client engagement president for IRI, a retail research firm, told CBS.

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This story was originally published February 18, 2022 at 9:05 AM with the headline "Baby formula that may be linked to 1 death, other hospitalizations prompts FDA warning."