FDA issues safety alert for infant formula due to Cronobacter contamination

The U.S. Food and Drug Administration is alerting parents and caregivers to safety concerns regarding the Cronobacter bacteria associated with Crecelac Infant Powdered Goat Milk Infant Formula and other infant formula products imported and distributed by Dairy Manufacturers Inc.

Although the company initiated a recall of the products on May 24 because they did not comply with all FDA regulations for infant formula, the FDA is now issuing this safety alert because of new evidence of Cronobacter contamination in a sample of Crecelac Infant goat milk formula.

As part of its investigation into this matter, on May 29, 2024, the FDA found Cronobacter in a sample of Crecelac Infant goat milk formula collected from a retail store in Texas.

In addition, FDA is alerting parents and caregivers of a recall initiated by Dairy Manufacturers Inc. of the Farmalac products listed above because they do not meet U.S. infant formula regulations. The company did not provide FDA with the required pre-notification to demonstrate the safety and nutritional adequacy of the infant formula. FDA continues to work with the company and its distributors to ensure the recall is effectively administered.

Cronobacter is a bacterium that can cause infections of the bloodstream and central nervous system such as sepsis or meningitis. Complications caused by Cronobacter Consequences of infection in infants can include brain abscesses, developmental delays, motor impairments, and death.

Symptoms of Cronobacter infection in infants may include nutritional deficiencies, irritability, temperature changes, jaundice, grunting breathing, or abnormal body movements.

The FDA is not currently aware of any illnesses associated with these products, and the FDA does not believe that the recall of these products will impact the infant formula supply.

The FDA is issuing this warning because infants who consume these products could be at risk for potentially serious infection due to Cronobacter contamination. The FDA advises parents and caregivers not to feed these infant formula products to infants in their care. If your infant exhibits symptoms consistent with Cronobacter infection, such as poor feeding, irritability, temperature fluctuations, jaundice, grunting breathing, or abnormal body movements, contact your healthcare provider to report symptoms and get immediate help.

If caregivers are looking for an alternative goat milk-based infant formula available for sale in the United States, they should speak with their infant’s doctor, as there are goat milk-based infant formulas that have either completed the required FDA premarket notification process or are currently marketed under FDA discretion.

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