Infant formula recall: FDA flags potential contamination in three products
10 Jun 2024 --- A new warning by the US Food and Drug Administration (FDA) has been issued about possible Cronobacter contamination of three products made for infants between zero and 12 months and a net weight of 12.4 oz (352g). These are the Crecelac Infant powdered goat-milk formula, Farmalac Baby powdered infant formula with iron and the Farmalac Baby formula with iron and low lactose.
The products are being sold in Texas and other locations in the US.
“The FDA is alerting parents and caregivers about Cronobacter safety concerns,” the governmental body notifies. “Although the company initiated a recall of the products referenced above on May 24, 2024, because they were not in compliance with all of the FDA’s infant formula regulations, the FDA is now issuing this safety alert due to new findings of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula.”
On 29 May of this year, the agency found Cronobacter in Crecelac Infant Powdered Goat Milk Infant Formula sample collected from a retail store in Texas.
Separately, the warning concerning Farmalac products by Dairy Manufacturers Inc. is being issued because of their failure to meet US infant formula regulations. The limited sampling of Farmalac products did not detect Cronobacter, however, the company failed to submit the required premarket notification to demonstrate the safety and nutritional adequacy of the formula. The FDA is working with the firm and distributors to safely remove the remaining products from the market.
Bacterial contamination
Cronobacter is a bacterium which can cause infections in the bloodstream and central nervous system, including sepsis and meningitis, respectively. Complications from such a bacterial infection in infants could lead to brain abscess, developmental delays, motor impairments and death.
The FDA has found Cronobacter in a Crecelac Infant Powdered Goat Milk Infant Formula sample.The symptoms of a Cronobacter infection among infants may include issues when feeding, irritability, temperature changes, jaundice, grunting breaths or abnormal body movements.
The FDA states that it is at this time not aware of illnesses associated with the products. It does not anticipate the infant formula supply to be affected based on the recall of these products.
The federal agency explains that the infant formula products got on the market illegally, having not submitted the necessary premarket notification, among other issues.
Parents and caregivers are advised not to feed these formulas to infants and to contact a healthcare provider immediately if they notice any of the affirmation symptoms in the case that it has already been consumed.
Cronobacter contamination was one of the main causes behind the 2022 infant formula crisis, during which an Abbott Nutrition plant was forced to close down due to safety concerns.
Last year, a study into the contamination of infant formula found that the pacing of samples over time in a stratified sampling pattern is the optimal approach to detecting pathogens like Cronobacter, as opposed to random sampling during production.
By Milana Nikolova
