FDA issues safety warning for infant formula due to Cronobacter contamination

The U.S. Food and Drug Administration is warning parents and caregivers about safety concerns about Cronobacter with Crecelac Infant Powdered Goat Milk Infant Formula and other infant formulas imported and distributed by Dairy Manufacturers Inc.

Although the company initiated a recall of the products on May 24 for failure to meet all FDA regulations for infant formula, the FDA is now issuing this safety alert due to new findings of Cronobacter contamination in a sample of Crecelac goat’s milk powdered 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 store in Texas.

In addition, the FDA is also warning parents and caregivers about 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 submit the required prior notification to the FDA to demonstrate the safety and nutritional value of the infant formula. The FDA continues to work with the company and its distributors to ensure the recall is implemented effectively.

Cronobacter is a bacterium that can cause infections in the bloodstream and central nervous system, such as sepsis and meningitis. Complications of Cronobacter infection in infants can include brain abscess, developmental delays, motor impairment, and death.

Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breathing, 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 infant formula supply based on the recall of these products.

The FDA is issuing this advisory because infants who consume these products may be at risk of a potentially serious infection due to Cronobacter contamination. The FDA advises parents and caregivers not to give these infant formula products to children in their care. If your child experiences symptoms related to a Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breathing, or abnormal body movements, contact your healthcare provider to report the symptoms and get immediate care.

If caregivers are looking for an alternative goat’s milk infant formula for sale in the US, they may want to speak with their child’s healthcare provider as there are goat’s milk infant formulas that have either passed the required FDA pre-market notification process completed or that have not yet been placed on the market. is currently marketed under FDA enforcement policies.

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