Hypoallergenic baby formula made in Michigan recalled for bacteria contamination
Kalea HallReckitt/Mead Johnson Nutrition is voluntarily recalling certain Nutramigen hypoallergenic infant formula powder products made at a Michigan facility due to possible bacteria contamination, the U.S. Food and Drug Administration said.
The recalled formula could be contaminated with cronobacter sakazakii, a pathogen found naturally in the environment that can enter manufacturing facilities on hands, shoes and other contaminated surfaces, according to the FDA. It can be difficult to detect since it can occur at very low levels and is not evenly distributed in products, according to the administration.
Though rare, cronobacterinfections can be life-threatening in newborns. Cronobacter germs can cause a dangerous blood infection (sepsis) and can make the linings surrounding the brain and spinal cord swell (meningitis), according to the Centers for Disease Control and Prevention. Cronobacterillness in infants often starts with a fever and poor feeding, excessive crying, or very low energy.
The recalled formula was produced at a Mead Johnson Nutrition facility in Zeeland and exported. The Israeli Ministry of Health notified the FDA on Dec. 14 that Nutramigen hypoallergenic powdered infant formula had initially tested positive for the cronobacter. At the time, the FDA did not have sufficient information based on the initial test at the Israeli border to warrant a product action, but the agency did start an investigation.
On Dec. 18, the FDA began an inspection at Reckitt/Mead Johnson Nutrition's Zeeland facility that included collecting environmental samples and testing additional samples of finished product from the same batch of Nutramigen tested by Israel. While the FDA’s inspection is ongoing, all testing conducted to date by the administration and the company has been negative for cronobacter.
On Dec. 28, the FDA received whole genome sequencing results from Israeli health officials that confirmed a finding ofcronobacter sakazakii, prompting the FDA to immediately contact Mead Johnson Nutrition and recommend a recall.
On Dec. 29, the company agreed to initiate a voluntary recall of 675,030 cans of Nutramigen powdered infant formula distributed to the United States. Reckitt/Mead Johnson Nutrition manufactured additional products and distributed them outside of the United States and will be contacting regulatory authorities in each of those countries.
In a Dec. 30 statement on its website, the company said the recalled 12.6-ounce and 19.8-ounce containers was manufactured in June 2023 and distributed primarily in June, July and August 2023.
No illnesses have been reported, and it's likely most of the product that was distributed in the United States has already been consumed, according to the FDA
Consumers who have Nutramigen Hypoallergenic Infant Formula Powder with batch codes below should stop using it and throw it away or contact Reckitt/Mead Johnson Nutrition for a refund:
- ZL3FHG (12.6 ounce cans)
- ZL3FMH (12.6 ounce cans)
- ZL3FPE (12.6 ounce cans)
- ZL3FQD (12.6 ounce cans)
- ZL3FRW (19.8 ounce cans)
- ZL3FXJ (12.6 ounce cans)
- The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of Jan. 1, 2025.
Nutramigen is a hypoallergenic infant formula for infants with allergies to cow’s milk. The FDA does not expect that the recall will have a major impact on supply and availability of powdered infant formulas in the United States. The administration has been in communication with other manufacturers to ensure there's a strong supply of the hypoallergenic product.
khall@detroitnews.com
@bykaleahall