Reckitt/Mead Johnson Nutrition, the makers of Nutramigen baby formula, have issued a voluntary recall of certain products due to concerns of potential contamination with cronobacter bacteria. The recall, announced on Sunday, has been prompted by fears that the formula may contain the bacteria, which can cause life-threatening infections such as sepsis and meningitis, particularly in infants allergic to lactose.
The recalled products include Nutramigen Powder infant formula in 12.6oz and 19.8oz cans that were produced in June and distributed throughout the summer. The Food and Drug Administration (FDA) has stated that it believes most of the recalled products have already been consumed, and as of December 31st, there have been no reports of illnesses or adverse events related to the recalled formula.
The concerns over potential contamination arose when the Israeli Health Ministry informed the FDA on December 14th that the Nutramigen formula had initially tested positive for Cronobacter species. However, further testing was required to determine if the sample was positive for cronobacter sakazakii, the specific bacterium known to cause serious illnesses. On December 28th, the Israeli tests confirmed the presence of cronobacter sakazakii, leading to the company's decision to initiate a voluntary recall the following day.
In response to the recall, the FDA launched an investigation at a Reckitt/Mead Johnson facility on December 18th and conducted additional testing. Although the investigation is still ongoing, all testing conducted thus far has come back negative for the presence of cronobacter bacteria.
Reckitt/Mead Johnson has assured parents that they can continue to use their other Nutramigen powder formula batches with confidence, emphasizing that the recalled products were manufactured in June 2023 and distributed primarily in June, July, and August of that year after testing negative for bacteria. The company's spokesperson stated, "Parents should be reassured that they can continue to feed their infants with Reckitt/Mead Johnson Nutrition products, including other Nutramigen powder formula batches, with confidence."
Cronobacter is a naturally occurring pathogen that can enter manufacturing facilities through various means. Formula producers are required by the FDA to test their products for both cronobacter and salmonella. However, despite these precautions, recalls related to cronobacter contamination still occur. In February, Reckitt recalled 145,000 cans of plant-based formula over suspected cronobacter contamination. Additionally, last year, Abbott Nutrition recalled three types of baby formula due to cronobacter contamination, resulting in four children falling ill and one later dying.
The recall serves as a reminder of the importance of rigorous testing and quality checks in the manufacturing process of baby formula to ensure the safety of infants. The FDA's ongoing investigation aims to determine the source of the contamination and prevent future incidents.
