The Food and Drug Administration (FDA) announced that a baby formula maker issued a voluntary recall of its formula after it found the “potential for cross-contamination” with a potentially deadly bacteria.
Cronobacter strains can cause life-threatening infections such as meningitis—or inflammation of the membranes around the brain and spine—or sepsis, which is a medical emergency in which the body’s reaction to an infection causes damage to tissues.
“Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements,” it said. “Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.”
The announcement stated that none of the distributed ByHeart products tested positive for any contaminants and that no consumer complaints were received. The recall, it said, was not triggered by the firm’s manufacturing facility in Reading, Pennsylvania.
The firm said that the recalled products are ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months in 24-ounce containers. The products were directly distributed to consumers in the United States.
People who purchased ByHeart products should look at the bottom of the infant formula container. They are urged to dispose of product from the affected batches.
“ByHeart owns its entire manufacturing supply chain with the exception of final canning, which is conducted by a reputable third-party packager,” the recall notice said. “ByHeart is taking this precautionary measure because one test sample collected from the third-party packaging facility tested positive for Cronobacter sakazakii.”
It added: “All product packaged that day, and the first production on the next day, was isolated for destruction and not distributed. Out of an abundance of caution, we are now recalling all product produced during the entire production run.”
The recall comes months after the closure of a Michigan plant run by Abbott, the largest maker of infant formula in the United States, due to potential contamination hazards. The closure triggered a months-long shortage of baby formula as federal officials investigated bacterial infections that led to four infant deaths.
