More than 675,000 cans of baby formula are being recalled over concerns they’ve been contaminated with a bacteria that could cause life-threatening health complications in infants.
Reckitt/Mead Johnson Nutrition (MJN) announced over the weekend it was voluntarily recalling select cans of its specialty infant formula, Nutramigen Powder – baby formula made for infants with an allergy to cow’s milk – because they could be contaminated with the bacteria Cronobacter sakazakii.
The company said products sold outside of the United States tested positive for the bacteria, but it has not been found in any batches tested in the US.
The recall applies to several batches of the formula in 12.6oz and 19.8oz cans manufactured in June 2023 that were distributed through retail stores nationwide between June and August.
Cronobacter sakazakii is a bacteria that lives in dry places, such as powered milk, herbal teas and powdered infant formula and infections with the bacteria can cause brain swelling and seizures in infants.
The recall applies to Nutramigen Powder – baby formula specially made for infants with an allergy to cow’s milk
The recall applies to several batches of the formula in 12.6oz and 19.8oz cans manufactured in June 2023
The recall does not apply to Nutramigen’s liquid formulas or the company’s other nutrition products and further testing of batches suspected to be contaminated have tested negative for the bacteria.
Reckitt/Mead Johnson Nutrition said in a press release: ‘The health and safety of infants is our highest priority. All of our products undergo rigorous and industry-leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration.
‘It is for this reason that we have confidence in the safety and quality of every infant formula we make.’
The Food and Drug Administration said it was notified on December 14 by the Israeli Ministry of Health that the Nutramigen product produced at the Mead Johnson Nutrition facility in Zeeland, Michigan and exported from the US had tested positive for Cronobacter.
The product was tested during a routine sampling at the Israeli border.
Following the test results, the FDA and Israeli officials conducted a whole genome sequencing on a sample from the affected formula to confirm the initial findings. Once confirmed, the FDA contacted Rickitt/Mead Johnson Nutrition and recommended a recall.
The FDA also began an inspection at the Michigan facility on December 18, taking additional samples. The investigation is ongoing, but all further samples have tested negative for the bacteria.
Cronobacter infections are rare, according to the Centers for Disease Control and Prevention, but they can be life-threatening in newborns.
About two to four cases are reported to the health agency every year, but the number is likely higher because hospitals and labs are not required to report Cronobacter infections to health departments.
The bacteria can cause a blood infection, or sepsis, and can cause the brain and spinal cord to swell.
Infants younger than two months old are most at risk and are most likely to develop meningitis.
Infants born prematurely and those with compromised immune systems are also at higher risk of infection.
Cronobacter infections usually begin with a fever, poor feeding, excessive crying and very low energy.
In severe cases, some infants may also suffer from seizures.
Cronobacter can get into infant formula if the manufacturer uses contaminated ingredients or if the bacteria is on surfaces and the powder comes into contact with it.
The bacteria is found naturally in the environment but is a health threat to young children with still-developing immune systems. It was also behind baby formula recalls in 2022.
The FDA said it has not received any illnesses in connection with the recall and because of its limited supply, it is likely all of the product available in the US has already been consumed.
The FDA advises anyone with cans of formula included in the recall to stop using it and throw the product away.
While the formula is a specialty product for infants with a cow’s milk allergy who cannot drink regular formula or breastfeed, there are alternative, equivalent products parents can use.
In 2022, the US experienced a severe baby formula shortage due to supply chain issues and two major formula recalls. However, the FDA said it does not expect this recall to have a major impact on the supply and availability of infant formula.
Additionally, the FDA said it has communicated with other manufacturers of hypoallergenic products to ensure ‘a robust supply’ of similar formulas.
It is not known exactly how many infants use the Nutramigen product, but it is estimated between two and five percent of babies and young children have an allergy to cow’s milk, which can be present in a mother’s breastmilk and in traditional formulas.
