The U.S. Food and Drug Administration is alerting parents and caregivers about Cronobacter safety concerns 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 were not in compliance with all of the FDA’s infant formula regulations, the FDA is now issuing this safety alert because of new findings of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula. As part of its investigation into this matter, on May 29, 2024, the FDA found Cronobacter in a sample of Crecelac Infant Powdered Goat Milk Infant Formula collected from a retail store in Texas. Separately, the FDA is also alerting parents and caregivers to a recall initiated by Dairy Manufacturers Inc.

of the Farmalac products listed above because of their failure to meet U.S. infant formula regulations.

The firm has not submitted the required premarket notification to the FDA to demonstrate the safety and nutritional adequacy of the infant formula. The FDA is continuing to work with the firm and its distributors to ensure the recall is effectively executed. Cronobacter is a bacterium that can cause bloodstream and central nervous system infections, such as sepsis and meningitis, respectively.

Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death. .