The recall applies to powder formulas, including Similac, Alimentum and EleCare, but does not include any metabolic deficiency nutrition formulas
Abbott Laboratories has announced a voluntary recall of certain baby powder formulas manufactured at its Sturgis, Michigan facility after complaints related to bacterial infections.
The voluntary recall applies to Similac, Alimentum and EleCare products, excluding any metabolic deficiency nutrition formulas.
The move follows complaints from four consumers about Cronobacter sakazakii or Salmonella Newport infections in infants who consumed the formula produced at the facility.
The US Food and Drug Administration (FDA) stated that it has started investigating consumer complaints regarding infections.
FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said: “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.
“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, four infant illnesses were reported from three states, and all four cases related to the complaints were hospitalised.
The Cronobacter infection may have contributed to a death in one case.
Cronobacter sakazakii is a commonly found bacteria that may cause fever, poor feeding, excessive crying or low energy as well as other serious symptoms.
Abbott said that as part of its quality processes, routine testing for Cronobacter sakazakii and other pathogens is conducted in our manufacturing facilities.
The company said the evidence of Cronobacter sakazakii was found in the Sturgis facility’s non-product contact areas during the testing, but no evidence of Salmonella Newport was found.
Also, no distributed product was found to host either of the bacteria, said the company.
Abbott nutritional products executive vice president Joe Manning said: “We know parents depend on us to provide them with the highest quality nutrition formulas. 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.”