Abbott Laboratories has initiated a voluntary recall of select powder baby formulas, including Similac, Alimentum, and EleCare manufactured in Sturgis, Michigan, following three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants.
All four babies became seriously ill and had to be hospitalized, and health authorities believe Cronobacter may have contributed to the death of one child. At this point, illnesses have been reported in Minnesota, Ohio, and Texas.
After launching an investigation, the US FDA has so far found several positive Cronobacter sakazakii results from environmental samples taken at a manufacturing plant. Abbott’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.
Abbott said samples related to the three complaints for Cronobacter sakazakii tested negative, and a sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.
Along with the Centers for Disease Control and Prevention (CDC) and state and local partners, the FDA is alerting consumers to avoid purchasing or using Similac, Alimentum, or EleCare powdered infant formulas if the products have a multi-digit number on the bottom of the container, starting with the first two digits 22 through 37, contains K8, SH, or Z2 and has an expiration date of April 1, 2022, or after.
“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,” said Frank Yiannas, the FDA’s deputy commissioner for food policy and response, in a statement. “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.”
The CDC says that Cronobacter illness is very rare, but it is often deadly in young infants, and typically the agency records two to four illnesses in infants each year. The bacteria can cause severe blood infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine).
Sickness from Cronobacter in babies will usually start with a fever and poor feeding, crying, or very low energy. Some babies may also have seizures. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
Newport is a strain of salmonella . The CDC says that most individuals infected with salmonella develop diarrhea, fever, and stomach cramps six hours to six days after exposure to the bacteria, and the illness usually lasts four to seven days. Most who are infected recover without treatment. Still, very young people can become seriously ill from the bacteria, and infection can spread from the intestines to the bloodstream and then on to other parts of the body.
On Monday, China customs warned consumers to not buy or eat Abbott formulas because of the FDA recall.
The recall comes at a difficult time for new mothers, because the United States has been struggling with a baby-food shortage, as reported by CNN Business .
“We know parents depend on us to provide them with the highest quality nutrition formulas,” said Joe Manning, the executive vice president of nutritional products for Abbott, in a statement.“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 healthcare professionals.”
