The U.S. Food and Drug Administration (FDA) has announced a new investigation concerning reports of Cronobacter sakazakii and Salmonella newborn infections connected to specific lots of Abbott Nutrition Infant Formula. According to the FDA’s warning, the affected baby formula was manufactured from Abbott Nutrition’s manufacturing facility in Sturgis, Michigan. The FDA is conducting the investigation with the U.S. Centers for Disease Control and Prevention as well as state and local officials. The FDA is warning consumers to avoid buying or feeding their babies with powdered infant formula products manufactured at the Michigan facility. The investigation is ongoing, and Abbott Nutrition is cooperating with the FDA by initiating a recall of the affected baby food products.
The FDA is urging consumers to stop using Alimentum, EleCare, or Similac powdered infant formulas if:
- the code on the package has SH, Z2, or K8; and
- if the first two numbers of the code contain 22 through 37; and
- if the product’s expiration date is April 1, 2022, or later.
The FDA is also currently investigating reports of four infant illnesses. In all four cases, the infants were hospitalized, and Cronobacter Sakazakii may have led to the tragic death of one infant. The FDA has begun an inspection at the Michigan facility. Findings from that inspection include multiple Cronobacter sakazakii positive test results performed on environmental samples collected by FDA investigators. A review of Abbott Nutrition’s internal corporate records also disclosed environmental contamination with Cronobacter Sakazakii and the history of the company’s destruction of infant food products due to Cronobacter Sakazakii contamination.
According to the FDA Deputy Commissioner for Food Policy and Response, Frank Yiannas, the FDA is very worried about these bacterial infections, especially since these products are the sole source of nutrition for newborns and infants. The FDA spokesperson also stated that the FDA is working hard to investigate the issue and resolve this safety problem as fast as possible.
The affected products manufactured at the Sturgis, Michigan, manufacturing plant were shipped to retailers throughout the United States and may have been exported to other countries. The FDA warning did not include metabolic deficiency nutrition formulas or liquid formula products.
Cronobacter Sakazakii bacteria can cause meningitis (inflammation of the brain and spine) and life-threatening infections such as sepsis. Symptoms of meningitis and sepsis include irritability, abnormal movements, poor feeding, temperature changes, grunting breaths, and jaundice (yellowing of the eyes and skin). Cronobacter infections can cause severe bowel damage and can spread to other body parts. Parents and caregivers of babies who have used these infant formula products should speak to their child’s medical professional. If your child experiences one or more of these symptoms, contact your child’s doctor and seek medical attention for your child immediately.
The FDA will continue to investigate these infant formula products and will deliver further consumer safety information as that information becomes available.
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