FDA Issues Safety Alert on Crecelac Infant Formula Due to Nutrient Imbalances and Bacterial Contamination

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WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently issued an urgent safety alert to warn consumers about the potential risks associated with Crecelac Infant Powdered Goat Milk Infant Formula. Recent testing revealed elevated levels of potassium and chloride, as well as insufficient levels of Vitamin A in the formula. These findings come despite a voluntary recall initiated by the company on May 24, 2024.

The FDA’s nutrient analysis found that the potassium and chloride levels in Crecelac’s formula significantly exceed the permissible limits for infant formulas in the United States. Prolonged consumption of these elevated levels could result in serious kidney and heart issues. Additionally, the low Vitamin A content could lead to vision problems due to Vitamin A deficiency.

Parents and caregivers are urged to discontinue the use of Crecelac Infant Powdered Goat Milk Infant Formula immediately. Those who have concerns about their child’s health should consult with healthcare providers.

Product Details

The recall concerns the following 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)

These products were sold in some retail stores in Texas and potentially other locations across the United States.

Bacterial Contamination

In addition to nutrient imbalances, the FDA discovered Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula collected from a Texas retail store on May 29, 2024. Cronobacter is a bacterium that can cause severe bloodstream and central nervous system infections, such as sepsis and meningitis. Symptoms in infants may include poor feeding, irritability, temperature fluctuations, jaundice, grunting breaths, or abnormal body movements. Complications can be severe, including brain abscesses, developmental delays, motor impairments, and even death.

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Additional Recalls

Separately, Dairy Manufacturers Inc. has recalled Farmalac products due to non-compliance with U.S. infant formula regulations. While no Cronobacter was detected in limited sampling of these products, the company failed to submit the required premarket notification to the FDA, which would ensure the products’ safety and nutritional adequacy.

FDA Recommendations

While the FDA is not aware of any illnesses linked to these products, they recommend that all consumers who have purchased the affected formulas discontinue their use immediately. The agency assures the public that this recall will not affect the overall supply of infant formula in the U.S.

For more detailed information on the recall and safety measures, parents and caregivers should visit the FDA’s official website or consult with healthcare providers.

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