The U.S. Food and Drug Administration (FDA) has issued a warning to parents and caregivers regarding safety concerns related to Cronobacter in Crecelac Infant Powdered Goat Milk Infant Formula and other similar products distributed by Dairy Manufacturers Inc.
While Dairy Manufacturers Inc. recalled these products on May 24 due to non-compliance with FDA regulations, the FDA is now issuing a safety alert following the discovery of Cronobacter contamination in a sample of Crecelac Infant Powdered Goat Milk Infant Formula. On May 29, the FDA found Cronobacter in a sample obtained from a retail store in Texas during its investigation.
Additionally, Dairy Manufacturers Inc. has initiated a recall of Farmalac Baby Powdered Infant Formula with Iron 0 to 12 months and Farmalac Baby Powdered Infant Formula with Iron Low Lactose 0 to 12 months due to regulatory non-compliance. Although limited sampling of these products did not detect Cronobacter, the firm failed to submit the necessary premarket notification to the FDA to ensure safety and nutritional adequacy.
Cronobacter is a bacterium that can cause severe infections such as sepsis and meningitis, particularly in infants, potentially leading to complications like brain abscess, developmental delays, motor impairments, and even death. Symptoms of Cronobacter infection in infants include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.
The FDA emphasizes that no illnesses related to these products have been reported thus far and anticipates no impact on the supply of infant formula due to the recall. However, the FDA has determined that these products were sold illegally in the U.S. due to the company’s failure to submit the required premarket notification.
Following the FDA’s recommendation, Dairy Manufacturers Inc. agreed to recall the infant formula products on May 21. The agency’s ongoing collaboration with the firm and its distributors aims to ensure an effective recall process.
Considering the potential risks associated with Cronobacter contamination, the FDA advises parents and caregivers against feeding these products to infants and urges immediate medical attention if any symptoms related to Cronobacter infection arise. Caregivers seeking alternative goat milk infant formulas in the U.S. are encouraged to consult their infant’s healthcare provider, as there are options available that comply with FDA regulations or are marketed under enforcement discretion.
For more information on safe infant feeding practices, parents and caregivers can visit the FDA’s infant formula landing page.
