Hundreds of thousands of cans of Nutramigen Hypoallergenic Infant Formula Powder, a specialty powdered baby formula used by infants with allergies to cow’s milk, have been recalled in the U.S. due to a potential bacterial contamination.
“No illnesses have been reported to date in connection with this recall, and it is likely most of the product that was distributed in the U.S. has already been consumed,” the FDA said in a statement on Dec. 31st.
The recall, the second from manufacturer Reckitt/Mead Johnson Nutrition in less than a year, comes two years after a major formula shortage sent parents scrambling to keep infants fed and raised questions about oversight in the formula industry.
Why was Nutramigen recalled?
On Dec. 29, Reckitt/Mead Johnson Nutrition announced a voluntary recall of 675,030 cans of Nutramigen powdered formula, after the Israeli Ministry of Health notified the FDA that batches of the formula exported from the U.S., had initially tested positive for Cronobacter species, bacteria that can be found in dry goods, during routine sampling. The bacteria can cause an infection known as cronobacter sakazakii, which can cause seizures and inflammation of the brain and spinal cord, among other things.
“Cronobacter can have fatal consequences for a newborn as their immune systems are very immature,” says Ann Kellams, a University of Virginia faculty pediatrician.
Kellams says that though it’s too early to tell if this will lead to another shortage, it seems unlikely. “There are some other companies that also make these hydrolyzed formulas,” she says, “We wouldn’t anticipate that this would spread to the other companies and makers of those products, because it’s specific to a specific brand and factory.”
The FDA claims there is no reason to worry. “The FDA does not expect that this recall will have a major impact on the U.S. supply and availability of powdered infant formulas, and the agency has been in communication with other manufacturers to request their assistance in ensuring a robust supply of hypoallergenic product,” the administration said in a statement.
What has caused previous disruptions in baby formula supply?
Kellams says that the complex process of creating formula—which involves collecting cows milk and processing it to resemble human’s milk— can lead to missteps. “There’s a lot of processing and handling steps, and each one of those steps has an opportunity to have contamination or a problem,” says Kellams, who adds that staffing shortages means that mistakes might not always get caught. “I think combined with the pandemic—which significantly contributed to staffing shortages and workforce issues like oversight issues— you can just imagine how that might invite errors along the process.”
For parents, the good news is that the Nutramigen recall is not nearly as big as the 2022 shortage— one of the largest baby formula shortages the U.S. had seen in decades. The shortage was mostly caused by supply chain strains created during the pandemic and was exacerbated by panic buying by parents and the shutdown of a major factory in Michigan due to concerns of Cronobacter contamination. (The manufacturer has since said that the FDA and CDC “did not find any definitive link between the company’s products and illnesses in children.”)
In the aftermath of the 2022 shortage, the FDA says that it has taken numerous steps to enhance the safety of formulas— through the development of a Cronobacter prevention strategy, enhanced inspections, and regulatory actions and has called for those involved in the manufacturing and distribution of powdered infant formula to share safety information.