FDA declared that the infant formula products mentioned above were unlawfully sold in the United States. One of the reasons for this determination is that the company failed to provide the necessary premarket notification to the FDA. In response, on May 21, 2024, the FDA advised the company to initiate a recall of the infant formula products, and the company agreed to comply with the recommendation.
The U.S. Food and Drug Administration (FDA) is warning parents and caregivers about Cronobacter safety concerns related to Crecelac Infant Powdered Goat Milk Infant Formula and other products imported and distributed by Dairy Manufacturers Inc.
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While the company recalled these products on May 24, 2024, for not meeting all FDA 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. During its investigation, the FDA found Cronobacter in a sample collected from a retail store in Texas on May 29, 2024.
Additionally, the FDA is informing parents and caregivers about a separate recall by Dairy Manufacturers Inc. of Farmalac products for failing to comply with U.S. infant formula regulations. Although limited testing of Farmalac products did not detect Cronobacter, the company has not provided the required premarket notification to the FDA to ensure the safety and nutritional adequacy of the infant formula. The FDA is working with the company and its distributors to ensure the recall is effectively carried out.
Cronobacter is a bacterium that can cause severe bloodstream and central nervous system infections, such as sepsis and meningitis. In infants, Cronobacter infection can lead to serious complications, including brain abscess, developmental delays, motor impairments, and death.
FDA declared that the infant formula products mentioned above were unlawfully sold in the United States. One of the reasons for this determination is that the company failed to provide the necessary premarket notification to the FDA. In response, on May 21, 2024, the FDA advised the company to initiate a recall of the infant formula products, and the company agreed to comply with the recommendation.
Symptoms of Cronobacter infection in infants may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.
Currently, the FDA is not aware of any illnesses related to these products and does not anticipate any impact on the infant formula supply due to the recall.
Caregivers seeking an alternative goat milk infant formula available in the U.S. should consult their infant's healthcare provider. There are goat milk infant formulas that have either completed the necessary FDA premarket notification process or are being marketed under the FDA’s enforcement discretion policy.
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.
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