FDA is investigating illnesses linked to powdered infant formula produced by Abbott Nutrition at a facility in Sturgis, Michigan.
In a news release Thursday, FDA said it is investigating complaints of four infant illnesses from Ohio, Minnesota and Texas.
The affected infant formula brands are Alimentum, EleCare and Similac.
All four infants affected were hospitalized, and Cronobacter—a germ the Centers for Disease Control and Prevention says naturally exists in the environment—may have contributed to a death in one case, FDA disclosed. Three of the infants were ill from Cronobacter and one of the cases is related to Salmonella, according to the agency.
Through an onsite inspection at Abbott Nutrition’s facility, FDA identified “several positive Cronobacter sakazakii results from environmental samples,” the agency said, adding its investigators found “adverse inspectional observations.”
The investigation remains ongoing, and FDA said it will furnish additional consumer safety information when it is available.
“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, FDA 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.”
In a voluntary recall notice of powdered formulas, Abbott Nutrition said it found evidence of Cronobacter sakazakii in “non-product contact areas” of its Sturgis plant during testing. On the other hand, the company found no evidence of Salmonella Newport.
“Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test,” the company added. “Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release.”
FDA reported the products produced at Abbott Nutrition’s Sturgis facility can be found across the U.S. and were probably exported to other countries. The agency is advising consumers not to use Similac, Alimentum or EleCare powdered infant formulas if the first two digits of the code are 22 through 37; the code on the container contains K8, SH or Z2; and the expiration date is 4-1-2022 (April 2022) or later.
Products are not impacted if they don’t meet the criteria above, and the advisory does not apply to liquid formula products or any metabolic deficiency nutrition formulas.
“We know parents depend on us to provide them with the highest quality nutrition formulas," Joe Manning, executive vice president of nutritional products with Abbott, said in the recall notice. "We're taking this action so parents know they can trust us to meet our high standards, as well as theirs. We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals."
FDA said Cronobacter bacteria can cause severe, life-threatening infections known as sepsis or meningitis, an inflammation of the membranes that protect the brain and spine.
“Cronobacter infections are rare, but they can be deadly in newborns,” CDC warns on its website. “Infections in infants usually occur in the first days or weeks of life. About two to four cases are reported to CDC every year, but this figure may not reflect the true number of illnesses because most hospitals and laboratories are not required to report Cronobacter infections to health departments.”
Salmonella can cause gastrointestinal illness and fever called salmonellosis, according to FDA. While most people with salmonellosis develop abdominal cramps, diarrhea and fever, more severe cases can result and some may become fatal, the agency said.
“We value the trust parents place in us for high-quality and safe nutrition, and we’ll do whatever it takes to keep that trust and resolve this situation,” an Abbott spokesperson said.
Previous baby food probe
FDA’s investigation into the powdered infant formula comes about a year after a congressional investigation revealed top-name baby foods contained dangerous levels of toxic heavy metals such as mercury, lead, arsenic and cadmium. That congressional probe led to an avalanche of proposed class action lawsuits against manufacturers of baby food.
FDA last year also released an action plan dubbed “Closer to Zero” to reduce exposure to toxic elements from food for babies and young children. FDA has described such efforts as "complicated and multifaceted."