FDA alerting parents, caregivers of Cronobacter safety concerns in certain infant formula

Image credit: FDA

Image Credit: FDA

Image Credit: FDA

Image Credit: FDA

The FDA recently alerted parents and caregivers of Cronobacter safety concerns linked to Crecelac Infant Powdered Goat Milk Infant Formula.¹

According to the alert, the federal agency conducted an abbreviated nutrient analysis of the formula and found both elevated levels of potassium and chloride, and low levels of vitamin A. The potassium and chloride levels were "significantly above the levels permitted in infant formula in the [United States] and could lead to kidney and/or heart problems if the infant formula is used for an extended period of time," the FDA said in the alert. The agency also noted that low vitamin A intake could lead to loss of vision from deficiency, if the infant formula is used for an "extended period of time."¹

The products in the alert include (images at right)¹:

• CRECELAC INFANT Powdered Goat-Milk Infant Formula with Iron 0 to 12 months - Net Wt. 12.4 oz (352g)
• Farmalac BABY Powdered Infant Formula with Iron 0 to 12 months Net Wt. 12.4 oz (352g)
• Farmalac BABY Powdered Infant Formula with Iron Low Lactose 0 to 12 months Net Wt. 12.4 oz (352g)

The products are being sold at some retail locations in Texas, and possibly at additional locations in the United States, according to the FDA. Dairy Manufacturers Inc issued a voluntary recall of the products on May 24, 2024. However, "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," the federal agency stated.^1,2

Cronobacter infection, a bacterium that can cause bloodstream and central nervous system infections, could lead to complications in infants such as brain abscess, developmental delays, motor impairments, and death.¹

The FDA is also alerting caregivers and parents to a recall initiated by the company of the Farmalac products because of their failure to meet infant formula regulations in the United States. The FDA noted that sampling of the Farmalac products did not result in Cronobacter detection, though the firm has not submitted the required premarket notification to the FDA demonstrating the safety and nutritional adequacy of the formula. The federal agency continues to work with the firm and relative distributors to ensure the recall is executed.¹

Poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements are possible symptoms of Cronobacter infection in infants. As of July 31, 2024, the FDA was not aware of any illnesses associated with the aforementioned products, nor does the FDA anticipate any impact on the supply of infant formula based on these recalls.¹

The FDA is advising caregivers and parents not to feed the affected infant formula products to infants under their care and to seek immediate care if the infant is experiencing Cronobacter symptoms.¹

References:

1. FDA alerts parents and caregivers to cronobacter safety concerns with Crecelac Goat Milk Infant Formula imported and distributed by Dairy Manufactureres Inc. FDA. Press release. July 31, 2024. Accessed August 5, 2024. https://www.fda.gov/food/alerts-advisories-safety-information/fda-alerts-parents-and-caregivers-cronobacter-safety-concerns-crecelac-goat-milk-infant-formula?utm_medium=email&utm_source=govdelivery
2. Dairy Manufacturers Inc. issues voluntary recall of products due to non-compliance with requirements under the 21 CFR 106.110 new infant formula registration. FDA. Press release. May 25, 2024. Accessed August 5, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-due-non-compliance-requirements-under-21