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FDA Alerts Parents and Caregivers to Cronobacter Safety Concerns with Crecelac Goat Milk Infant Formula Imported and Distributed by Dairy Manufacturers Inc. | FDA

Nancy

May 31

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U.S. Food and Drug Administration

Audience

Parents and caregivers of infants who consume infant formula.

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.

Purpose

The U.S. Food and Drug Administration (FDA) 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 referenced above on May 24, 2024, because they were not in compliance with all of the FDA's 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. 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. Limited sampling of the Farmalac products did not detect Cronobacter; however, 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.

Summary of Problem and Scope

The FDA has determined that the infant formula products listed above were sold in the U.S. illegally because, among other things, the company has not submitted to the FDA the required premarket notification.

On May 21, 2024, the FDA recommended that the firm recall the infant formula products to which the firm agreed. As the FDA continued its investigation, the agency identified Cronobacter in a sample of the recalled Crecelac infant formula product. The FDA notified Dairy Manufacturers Inc. of these findings and they agreed to update their recall press release to include the laboratory results.

The FDA is continuing to work with the firm and its distributors to ensure the recall is effectively executed.

Further Information for Consumers

The FDA is issuing this advisory because infants that consume these products could be at risk of potentially severe infection due to 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.

Additionally, parents and caregivers can find more information on safe infant feeding practices on the FDA's infant formula landing page.