The US Food and Drug Administration (FDA) has played down concerns that a recent product recall initiated by a major infant formula manufacturer could affect the supply and availability of formula in the US.
What happened?
- December 14 - The Israeli Ministry of Health notifies the FDA that Nutramigen Hypoallergenic Powdered Infant Formula produced at the Zeeland, Michigan facility of Mead Johnson Nutrition had initially tested positive for Cronobacter. In consultation with the FDA, Israel carries out whole genome sequencing (WGS) on the sample to confirm the initial result and determine the isolate.
- December 18 – FDA inspects the Reckitt/Mead Johnson Nutrition’s facility, collecting environmental and product samples. All tests have so far been negative for contaminants, but the inspection continues.
- December 28 – WGS results from Israel confirm a finding of Cronobacter sakazakii. FDA contacts Mead Johnson Nutrition and recommends a recall.
- December 29 – The manufacturer agrees to initiate a voluntary recall of 675,030 cans of Nutramigen powdered infant formula distributed to the US.
- December 30 - The voluntary recall is announced.
On December 29, 2023, Reckitt/Mead Johnson recalled 675,030 cans of Nutramigen Hypoallergenic Infant Formula Powder in 12.6 and 19.8oz containers after a product exported from the US to Israel tested positive for Cronobacter during routine testing at the Israeli border earlier that month. Further testing involving whole genome sequencing on the sample confirmed the initial result and determined that the isolate was Cronobacter sakazakii.
Cronobacter can cause sepsis, a severe and potentially life-threatening infection, as well as meningitis, with symptoms including fever, jaundice, breathing difficulties, and poor feeding.
FDA said Cronobacter is found naturally in the environment and can enter homes or manufacturing plants through contaminated surfaces, such as hands, shoes, and others. Even though manufacturers are required to test their product for Cronobacter, this still doesn’t guarantee the contents are pathogen-free, as contamination can occur at low-levels and be unevenly distributed throughout the product, making this pathogen difficult to detect.
Much of the recalled products ‘have been consumed’
Reckitt/Mead Johnson said containers of the recalled batches were produced in June 2023 and distributed during June, July and August 2023. Based on the limited availability of the remaining stock, the manufacturer thinks much if not all of the products recalled in the US have already been consumed. The products were distributed through retail stores nationwide and there are no reports of illnesses or adverse events to date, the company added.
The recalled product batch codes and can sizes are listed below.
- ZL3FHG (12.6 oz cans)
- ZL3FMH (12.6 oz cans)
- ZL3FPE (12.6 oz cans)
- ZL3FQD (12.6 oz cans)
- ZL3FRW (19.8 oz cans)
- ZL3FXJ (12.6 oz cans)
The products have a UPC Code of 300871239418 or 300871239456 and use-by date of 1 Jan 2025. Product with the batch codes listed above should be disposed of and the manufacturer can be contacted for a refund.
FDA is currently carrying out an inspection of the Michigan facility and has collected environmental samples as well as samples of finished product from the same batch tested by Israel. All testing carried out by FDA so far has come back negative, with Reckitt/Mead Johnson stating that its own testing of the batches has also tested negative for Cronobacter and other bacteria.
Outside the US, the manufacturer is contacting regulatory authorities in other countries where additional products made during the same product campaign had been distributed.
