FDA

Audience

• Parents and caregivers of infants who consume infant formula.

Products

• 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)

Products are being sold at some retail stores in Texas and, possibly, additional locations in the U.S.

The U.S. Food and Drug Administration (FDA) 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 referenced above on May 24, 2024, 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. 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. Limited sampling of the Farmalac products did not detect Cronobacter; however, 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.

Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.

At this time, the FDA is not aware of any illnesses associated with these products and the FDA does not anticipate any impact on the supply of infant formula based on the recall of these products.