Another Infant Fatality Tied to Recalled Formula; Five Babies Now Reported Sick

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An additional infant has tragically passed away after contracting cronobacter sakazakii bacteria, leading to an expansion of the recall of powdered infant formulas by Abbott. As of February 28, the FDA reported that the total number of hospitalizations has risen to five, with two fatalities. Four of the affected infants were diagnosed with cronobacter sakazakii, while one had salmonella. Both deceased infants were infected with cronobacter sakazakii. The cases have been documented across three states: Minnesota, Ohio, and Texas.

The latest infant death is connected to Similac 60/40, a specialized formula that was not part of the initial recall announced on February 17. This particular formula was distributed in the U.S. and Israel and is now included in the recall. The earlier recall pertains to powdered formulas including Similac, Alimentum, and Elecare, while liquid formula products remain unaffected. These formulas were widely distributed throughout the U.S. and likely to other countries.

Recall Criteria

The first recall includes formulas that meet the following criteria:

  • The first two digits of the code are 22-37;
  • The container code includes K8, SH, or Z2;
  • The expiration date is April 1, 2022, or later.

As an update, the Similac 60/40 formula with lot codes 27032K80 (can) and 27032K800 (case) is now under recall.

The FDA also urges caregivers to avoid diluting (or “watering down”) infant formula or using homemade versions. Consumers with affected products can either dispose of them or return them for a refund. Families utilizing the WIC program should either exchange the formula at the store or contact Abbott for assistance.

During an investigation at Abbott’s Sturgis, Michigan facility, the FDA discovered several positive results for cronobacter sakazakii in environmental samples and noted “adverse inspectional observations.” The FDA’s review of Abbott’s internal documentation revealed contamination with cronobacter and the destruction of contaminated products.

Abbott maintains that its internal testing has not detected cronobacter in its formulas, although the bacteria was found in non-product contact areas. “Given that this product serves as the primary source of nutrition for many of our nation’s newborns and infants, the FDA is particularly alarmed by these reports of bacterial infections,” stated Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

Health Risks

Cronobacter can lead to serious infections, such as sepsis and meningitis, which can be life-threatening. Symptoms in infants may include poor feeding, irritability, fever, jaundice, grunting breaths, and abnormal movements. Premature and immunocompromised infants are at a higher risk. Salmonella infection symptoms typically include fever and diarrhea, with severe cases leading to lethargy, rashes, and blood in urine or stool. Parents noticing any of these symptoms should consult their pediatricians.

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Summary

An infant death linked to cronobacter sakazakii has prompted an expanded recall of Abbott’s powdered formula, with five babies now reported ill. The FDA is urging families to check their products against the recall list and monitor symptoms associated with these infections.

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