Abbott is voluntarily recalling several infant formulas after reports of four babies being sickened with cronobacter sakazakii and salmonella Newport bacteria
The FDA is investigating the reports and says that cronobacter infection may have contributed to the death of one infant.
The recall involves powdered Similac, Alimentum, and EleCare formulas produced in Abbot Nutrition’s Sturgis, Michigan facility. The formula was distributed across the U.S. and likely to other countries. Liquid formula products and metabolic deficiency nutrition formulas are not impacted by this recall.
The formula being recalled meets 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.
Any container of formula that meets these criteria should not be used. Consumers can either discard the formula or return it for a refund.
The four cases of illness reported occurred in Minnesota, Ohio and Texas. Of the four infants hospitalized, three were infected with cronobacter and one with salmonella, with cronobacter infection having potentially contributed to one infant’s death.
In its onsite investigation of Abbott’s Sturgis, Michigan facility, the FDA has 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.
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