FDA issues safety alert for infant formula because of Cronobacter contamination

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.

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.

The FDA is issuing this advisory because infants that consume these products could be at risk of potentially severe infection because of the Cronobacter contamination. The FDA advises parents and caregivers not to feed these infant formula products to infants under their care. If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements, contact your health care provider to report their symptoms and receive immediate care.

If caregivers are looking for an alternative goat milk infant formula for sale in the U.S., they may wish to speak with their infant’s health care provider, as there are goat milk infant formulas that either have completed the required FDA premarket notification process or are currently being marketed under the FDA’s enforcement discretion policy.

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