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FDA Tells Consumers to Throw out Certain Powdered Infant Formulas due to Contamination

By Food Safety Tech Staff
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Abbott voluntarily recalled several products manufactured at its Sturgis, Michigan plant following complaints of Cronobacter sakazakii or Salmonella Newport illnesses in infants. One illness may have contributed to an infant death.

–UPDATE–March 14, 2022 — In an agency update, the FDA stated that it has removed the Salmonella Newport illness that was previously noted in the investigation. “In the early stages of this investigation, FDA included all consumer complaints of illness with exposure to products from the Sturgis, MI, facility. After further investigation, the FDA has determined that there is not enough information to definitively link this illness to powdered infant formula. CDC confirmed that this single Salmonella illness is not linked to an outbreak. The FDA and CDC are continuing to monitor for Salmonella cases and consumer complaints that may be related to this incident,” the FDA stated.

–END UPDATE–

Earlier this week Abbott issued a recall of infant powdered formulas (including Similac, Alimentum and EleCare) that were manufactured at the company’s Sturgis, Michigan plant. The company received consumer complaints in infants who had consumed powdered infant formula manufactured in this facility—specifically, three reports of Cronobacter sakazakii and one report of Salmonella Newport. All cases resulted in hospitalization, and one death was reported.

FDA began onsite inspection at the facility and thus far has found several positive Cronobacter results from environmental samples and reported adverse inspectional observations. “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,” FDA stated in a CFSAN update.

The recalled Similac, Alimentum and EleCare products can be identified by their 7-to-9 digit code and expiration date:

  • First two digits of the code are 22 through 37 and
  • Code on the container contains K8, SH, or Z2, and
  • Expiration date of 4-1-2022 (APR 2022) or later.

In a company announcement published on FDA’s website, Abbott stated, during testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.” It added that “no distributed product has tested positive for the presence of either of these bacteria” but that the company will continue to conduct testing.

Parents and caregivers can find out whether the product they have is included in the recall by visiting the Similac recall website.

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