Another Infant Death Linked To Recalled Formula

An additional infant has died after being sickened with cronobacter sakazakii bacteria; Abbott has expanded the list of powdered infant formulas under recall

The FDA announced Tuesday, Feb. 28, that another infant death has been attributed to powdered formula produced in Abbott’s Sturgis, Michigan, facility. A total of five hospitalizations have now been reported, with two deaths. Four of the babies were infected with cronobacter sakazakii bacteria, and one with salmonella. Both of the infants who died were infected with cronobacter sakazakii. The illnesses were reported in three states: one in Minnesota, two in Ohio, and two in Texas.

The most recent infant death is linked to Similac 60/40, a specialty formula that was not included in Abbott’s initial recall announced on February 17. The Similac PM 60/40 formula was distributed in the U.S. and Israel and is now also under recall.

The Feb. 17 recall involves powdered Similac, Alimentum and Elecare powdered infant formulas. Liquid formula products are not impacted. These formulas were distributed across the U.S. and likely to other countries.

The initial recall affects formulas that meet all of the following criteria:

• The first two digits of the code are 22-37; and
• The code on the container contains K8, SH or Z2; and
• The expiration date is 4-1-2022 (APR 2022) or later.

In addition, as of Feb. 28:

• Similac 60/40 formula with lot codes 27032K80 (can) and 27032K800 (case) is being recalled.

The FDA also reminds caregivers never to dilute (“water down”) infant formula or use homemade formula.

Consumers with product that meets the above criteria can either discard the formula or return it for a refund. Families who get formula through WIC should return the formula to the store for exchange or refund, or call 1-800-986-8540 for assistance.

In its onsite investigation of Abbott’s Sturgis, Michigan facility, the FDA found several positive cronobacter sakazakii results from environmental samples. The FDA also found “adverse inspectional observations” at the facility. In addition, a when the FDA reviewed Abbott’s internal records, it found environmental contamination with cronobacter sakasakii, and that Abbott had destroyed formula found to be contaminated with cronobacter.

Abbott says that its internal testing has not found evidence of cronobacter in its formula, but that it had found the bacteria in tests from “non-product contact areas.”

“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,” says Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

Cronobacter can cause a life-threatening infection (sepsis) or meningitis (inflammation of the membranes surrounding the spine and brain). Cronobacter may spread to other parts of the body and is known to cause bowel damage. Symptoms of sepsis and meningitis in an infant include poor feeding, irritability, temperature changes (such as fever), jaundice (a yellowing of the skin and the whites of the eyes), grunting breaths, and abnormal movements. Premature or immunocompromised infants are at an increased risk.

The most common symptoms of infection with salmonella bacteria include fever and diarrhea. Serious infections can also cause lethargy, a rash, and blood in urine or stool.

If your baby is experiencing any of these symptoms, you should contact your pediatrician.

Parents or customers with impacted product can visit similacrecall.com or call +1-800-986-8540.