FDA issues safety alert for infant formula over health risks

The U.S. Food and Drug Administration (FDA) has issued a safety alert for parents and caregivers regarding several infant formula products that are non-compliant with federal safety standards. 

The products in question include Crecelac and Farmalac brand formulas, which have been linked to serious health risks for infants.

The alert follows a recall initiated by Dairy Manufacturers Inc. on May 24, 2024, which was prompted by the discovery of elevated levels of potassium and chloride and low levels of Vitamin A in Crecelac Infant Powdered Goat Milk Infant Formula. Such imbalances pose significant health risks, including potential kidney and heart problems from high levels of potassium and chloride, and vision problems from Vitamin A deficiency if consumed over a prolonged period. Although the recalled products were removed from shelves, the FDA is concerned that some households may still have these products. 

Further compounding the issue, the FDA’s ongoing investigation led to the discovery of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula collected from a retail store in Texas. Cronobacter is a bacterium known to cause severe infections in infants, such as bloodstream infections and meningitis, which can lead to long-term neurological damage or even death.

The affected products were distributed in various states, primarily in Texas, and include:

• Crecelac Infant Powdered Goat-Milk Infant Formula with Iron (0 to 12 months)
• Farmalac BABY Powdered Infant Formula with Iron (0 to 12 months)
• Farmalac BABY Powdered Infant Formula with Iron Low Lactose (0 to 12 months)

Symptoms of Cronobacter infection in infants include poor feeding, irritability, temperature changes, jaundice, and abnormal movements. Parents and caregivers who observe these symptoms are urged to seek immediate medical attention.

Consumers are advised to discontinue use immediately and consult healthcare providers if their child has consumed the formula.

Adding to the severity, Dairy Manufacturers Inc. did not complete the required premarket notification for the Farmalac products, which is necessary to demonstrate safety and nutritional adequacy.

The FDA reassures the public that no illnesses linked to these recalls have been reported so far, and the recall is not expected to impact the overall supply of infant formula in the country.

Parents and caregivers seeking alternatives are advised to discuss other goat milk formula options with their child’s healthcare provider.

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