FDA Announces New Potential Health Concerns for Recently Recalled Baby Formula
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More potential health concerns have been uncovered in Dairy Manufacturers Inc.’s Crecelac baby formula following an analysis conducted by the Food and Drug Administration.
The recently recalled goat’s milk formula was found to contain both potassium and chloride levels “significantly above” what is permitted in baby formula in the United States, according to the FDA.
These high levels could lead to both kidney and heart problems in infants if the formula is used for an extended period of time. The abbreviated nutrient analysis also found the formula to have low levels of Vitamin A, which can potentially result in vision loss from vitamin deficiency.
Any families still in possession of Crecelac are urged to discontinue use, according to the FDA.
This is the latest in a growing list of baby formula health concerns in recent years. Cronobacter contamination contributed to a nationwide baby formula shortage in 2022, and more than 600 baby formula lawsuits filed in federal court claim Similac and Enfamil formulas have caused necrotizing enterocolitis.
Crecelac’s 2024 Baby Formula Recall and Cronobacter Contamination
Dairy Manufacturers Inc. issued a voluntary recall of its Crecelac product in May after it was determined that the formula was not in compliance with FDA baby formula regulations. Two types of its Farmalac baby formula were also included in the recall.
The FDA later issued a safety alert after its investigation into the affected products uncovered Cronobacter contamination in a sample of Crecelac. According to the Centers for Disease Control and Prevention, Cronobacter can cause serious medical conditions, such as sepsis and meningitis, in infants.
Infants who are younger than two months, were born prematurely or have weakened immune systems are the most likely to be affected by Cronobacter.
While these infections are rare, they can be life-threatening to newborns. So far, the FDA has not uncovered any illnesses that developed as a result of the recalled baby formula.
The products impacted by the recall were primarily sold in Texas, but the FDA warned that they may have been available in other states as well.
Baby Formula Health Concerns on the Rise as Lawsuits Result in Huge Verdicts
The Crecelac recall is far from the first instance of health concerns related to baby formula in recent years.
A nationwide formula shortage in 2022 was triggered in part by the detection of Cronobacter in an Abbott Laboratories factory. The facility was shut down and a nationwide recall took place.
There are also ongoing lawsuits against Abbott and Mead Johnson over claims that their cow’s milk baby formulas are linked to the development of necrotizing enterocolitis in newborns.
NEC is a serious intestinal condition that causes inflammation and can lead to bacterial infections or tissue damage. It can result in the death of the infant with a fatality rate ranging from 15% to 40%.
Litigation has centered around the use of Enfamil and Similac baby formulas for prematurely born infants. Plaintiffs have alleged that the manufacturers failed to warn about the potential risks of premature newborns developing NEC when fed cow’s milk formula.
Abbott was ordered to pay $495 million in damages last week to the family of a baby that developed NEC and suffered irreversible brain damage after being fed Similac formula.
Mead Johnson was ordered to pay $60 million in March to the family of an infant who died from NEC after being fed Enfamil.
The Crecelac recall and safety alert are not included in the ongoing litigation surrounding cow’s milk baby formula.