The Food and Drug Administration announced Thursday that it is investigating certain powdered infant formula following four customer reports of children contracting serious infections.
In a news release, the FDA said infections stemming from the bacterium Cronobacter sakazakii and the strain Salmonella Newport have been linked to powdered infant formula produced in Abbott Nutrition’s Sturgis, Michigan, facility.
The FDA’s investigation includes four infant illnesses in three states — Minnesota, Ohio and Texas — that possibly connect to the products and infections.
According to the administration, all four patients were hospitalized and one death might be connected to the Cronobacter sakazakii bacterium.
Consumers are advised to avoid certain powdered infant formula products that come from that location while the administration works with the Centers for Disease Control and Prevention, as well as state and local partners, to examine the reports.
The FDA said buyers should avoid Similac, Alimentum and EleCare formulas if they meets all of the following criteria:
- The first two digits of the code are 22 through 37.
- The code on the container includes K8, SH or Z2.
- The expiration date is 4-1-2022 (APR 2022) or later.
Parents can also type in the code on the bottom of the package at similacrecall.com to see whether their product is affected or call 800-986-8540.
The FDA advisory also clarified that liquid formula products or metabolic deficiency nutrition formulas are not included in the warning.
“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections,” Frank Yiannas, the FDA’s deputy commissioner for food policy and response, said in the news release. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible.”
According to the FDA, symptoms of Cronobacter infection include life-threatening infections like sepsis, meningitis, temperature changes and bowel damage. Salmonella can also cause life-threatening conditions. Other symptoms include fever, abdominal cramps, aches, fever and diarrhea.
If parents or caregivers notice that an infant has those symptoms or has recently consumed those products, the FDA encourages them to contact a health care provider and get medical care immediately.
In a statement, Abbott Nutrition issued a voluntary recall for the affected products and said its testing showed that no distributed product has tested positive for the presence of either bacterium.
“Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii,” the statement said. “And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.”
In a statement to NBC's "TODAY" show, a spokesperson said Abbott Nutrition values the trust of parents to provide safe food for their kids and that it will “do whatever it takes to keep that trust and resolve this situation.”
The FDA warning comes amid a baby formula shortage. Major chains like CVS, Walmart and Target are battling supply issues.
Dr. Kate Lockwood, a pediatrician at Children’s Hospital of Philadelphia, previously spoke to "TODAY" about tips parents and caregivers can use to feed their children.
Lockwood said doctors can request special shipments for their patients who are in need of particular formulas. She also said doctors can suggest regulated breast milk banks to use.
“Sometimes smaller mom-and-pop stores carry formula,” Lockwood said. “Think about places that might not have their shelves wiped out, like family-owned pharmacies and convenience stores.”
Lockwood and the FDA warned against making formula at home. The agency cautioned that making formula can cause “very serious health concerns” for babies.
