U.S – In response to the recent recall initiated by Reckitt/Mead Johnson, a major infant formula manufacturer, the US Food and Drug Administration (FDA) has sought to allay concerns surrounding the recall of Nutramigen Hypoallergenic Infant Formula Powder.
The recall, affecting 675,030 cans in 12.6 and 19.8oz containers, was prompted by the detection of Cronobacter sakazakii during routine testing at the Israeli border on a product exported from the US.
Cronobacter sakazakii is a bacterium that can cause severe and potentially life-threatening infections, including sepsis and meningitis, with symptoms ranging from fever and jaundice to breathing difficulties and poor feeding.
The FDA emphasized that Cronobacter is naturally present in the environment and can enter manufacturing plants or homes through contaminated surfaces.
Despite manufacturers being required to test their products for Cronobacter, the agency highlighted that this doesn’t guarantee absolute pathogen-free content. Contamination can occur at low levels and may be unevenly distributed throughout the product, making detection challenging.
Reckitt/Mead Johnson’s recall pertains to products produced in June 2023, with distribution occurring in June, July, and August 2023. The manufacturer believes that a significant portion, if not all, of the recalled products in the US may have already been consumed. The affected items were distributed nationwide through retail stores.
The recalled product batches include codes ZL3FHG, ZL3FMH, ZL3FPE, ZL3FQD, ZL3FRW, and ZL3FXJ, with UPC Codes of 300871239418 or 300871239456 and a use-by date of January 1, 2025. Consumers are advised to dispose of products with these batch codes and can contact the manufacturer for a refund.
Reassuringly, there have been no reports of illnesses or adverse events related to the recalled products.
The FDA is currently conducting an inspection of the Michigan facility where the formula was produced and has taken environmental samples, along with samples of finished products from the same batch tested by Israel.
Both FDA and Reckitt/Mead Johnson reported negative results for Cronobacter and other bacteria in their respective tests.
Beyond the US, Reckitt/Mead Johnson is actively engaging with regulatory authorities in other countries where additional products from the same production campaign have been distributed.
The FDA remains vigilant in monitoring the situation and ensuring the safety of infant formula products in the market.