Abbott Laboratories said it is recalling three types of baby formula after consumer complaints of bacteria contamination that could cause severe illness in infants.
The Food and Drug Administration is investigating complaints of four infant illnesses in Minnesota, Ohio and Texas related to cronobacter and salmonella contamination. All four infants were hospitalized and one died. Cronobacter may have contributed to that death, the agency said.
Cronobacter illnesses, which include sepsis and meningitis, are rare but can be lethal for infants, according to the Centers for Disease Control and Prevention. Salmonella can cause fever and digestive issues, and sometimes severe illness, according to the CDC.
Abbott said Thursday it was voluntarily recalling its Similac, Alimentum and EleCare formulas manufactured in its Sturgis, Mich., plant and with an expiration of April 1 or later. The recall doesn’t include any metabolic deficiency nutrition formulas, the company said. The FDA said the Abbott facility in Sturgis isn’t producing or distributing product at this time.
An Abbott spokeswoman said the company will address the scope of the recall at a later date. She added that the four complaints came between September 2021 and January.
The FDA began an inspection of the Sturgis plant on Jan. 31, and said cronobacter was present in environmental samples. Abbott’s internal records indicated environmental contamination with cronobacter and that the company had destroyed product due to its presence, an FDA review found.
“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 a statement Thursday. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products."
Abbott said that it tests for pathogens including cronobacter and salmonella before releasing its products. The company said none of its distributed product tested positive for the presence of either bacteria thus far, and that more testing is ongoing. The recalled products were distributed across several states and to countries outside the U.S.
“We know parents depend on us to provide them with the highest quality nutrition formulas," said Joe Manning, executive vice president of nutritional products at Abbott. “We’re taking this action so parents know they can trust us to meet our high standards, as well as theirs."
The CDC says powdered infant formula can’t be sterilized. Bacteria could get into formula powder if contaminated raw materials were used to make the formula, or if the formula touched a contaminated surface during the manufacturing process. It could also become contaminated at home, the CDC says.
The products under recall have a multidigit code in which the first two digits are 22 through 37, the code contains K8, SH or Z2, and the expiration date is April 1 or later.
Consumers can call +1-800-986-8540 or visit similacrecall.com to find out if their product is included in the recall.
This story has been published from a wire agency feed without modifications to the text
