FDA issues safety warning for infant formula due to health risks

The U.S. Food and Drug Administration (FDA) has issued a safety alert to parents and caregivers regarding several infant formula products that do not meet federal safety standards.

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

The warning follows a recall initiated by Dairy Manufacturers Inc. on May 24, 2024, following 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 potassium and chloride levels, and vision problems from vitamin A deficiency if consumed over an extended period of time. Although the recalled products have been removed from shelves, the FDA is concerned that some households may still have these products in their possession.

Compounding the problem, 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 store in Texas. Cronobacter is a bacterium known to cause serious 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 several states, primarily in Texas, and included:

• Crecelac Infant formula in powder form of goat’s milk with iron (0 to 12 months)
• Farmalac BABY infant formula in powder form with iron (0 to 12 months)
• Farmalac BABY infant formula in powder form with low-iron 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 notice these symptoms are urged to seek immediate medical attention.

Consumers are advised to discontinue use immediately and consult a doctor if their child has used formula.

Adding to the seriousness, Dairy Manufacturers Inc. has not completed the required pre-market notification of the Farmalac products, which is necessary to demonstrate the safety and nutritional adequacy.

The FDA assures the public that no illnesses associated with these recalls have been reported to date, and the recall is not expected to impact the nation’s overall infant formula supply.

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

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