FDA Issues New Safety Alert for Infant Formula Due to Cronobacter Contamination

The US Food and Drug Administration has issued a new warning that three products produced for infants aged 0-12 months with a net weight of 12.4 oz have possibly been contaminated by Cronobacter. The products, which are sold in Texas and other locations across the country, are the Farmalac Baby powdered infant formula with iron, the Farmalac Baby formula with iron and low lactose and the Crecelac Infant powdered goat-milk formula.

The FDA warning alerted caregivers and parents about the potential Cronobacter contamination, and noted that the governmental body needed to issue the safety alert following new findings of potential contaminations in a product sample, despite the products being recalled by the company on May 24, 2024. The warning is being issued separately regarding the products by Dairy Manufacturers Inc. due to the company’s failure to comply with US infant formula regulations.

The limited samples did not detect the bacteria, but the company did not submit the mandatory premarket notification to prove the formula’s nutritional adequacy and safety. The firm and distributors are working together with the FDA to remove the flagged products from the market.

Cronobacter sakazakii can cause diarrhoea and fever, as well as meningitis and sepsis in more serious cases. In late December 2023, the FDA announced a recall of thousands of cans of infant formula produced by Reckitt-owned Mead Johnson Nutrition. The recall came after Cronobacter sakazakii was discovered in cans imported into Israel from the US and reported by Israeli health authorities.

In 2021 President Joe Biden’s administration announced plans to address the amount of toxic heavy metals found in baby foods. The FDA faced heavy criticism for being slow to act on limiting infants’ exposure to heavy metals. The reports from 2021 found unsafe levels of arsenic, cadmium and lead in products sold by leading baby food companies.

Cronobacter contamination of infant formula was the main reason for a dire shortage of infant formula in 2022 that resulted from an Abbott Nutrition plant ceasing production due to safety issues. Parents and caretalers are being advised to immediately contact a healthcare provider if they observe any symptoms in the event that the potentially contaminated formula has already been consumed.

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