Similac (dairy formula for children)

2022

2023: Removal from sale of infant formula after the death of a child

On October 30, 2023, Abbott announced it was discontinuing sales of all probiotic-based infant formula. The reason was the warnings of the regulatory authorities after the death of the child due to the product.

The decision to halt sales of the Similac Tri-Blend was made on October 26, 2023, when Food and Drug Administration (FDA - Food and Drug Administration)\ The U.S. Food and Drug Administration issued a warning that said the products contained living organisms (yeast and bacteria) that could be dangerous to infants.

Abbott announced it will stop selling all probiotic-based infant formula

The FDA also sent a warning letter to Abbott, indicating that Bifidobacterium infantitis and Streptococcus thermophilus bacteria were found in Similac Tri-Blend. According to the FDA, B. Infantitis is unsafe to add to food, and S. Thermophilus is a new and not fully studied bacterium, information about which is not enough to consider it safe and add to food, especially for babies.

A month earlier, the Office issued a letter to medical organizations warning of the infant's death after consuming a probiotic formula due to the formation of sepsis. It's all about Abbott promoting their product as curative, capable of reducing infant mortality, which reduces the risk of sepsis and necrotising enterocolitis.

The FDA is concerned that these products are unsafe for premature infants and are sold illegally, as curative and able to reduce the risk of necrotising enterocolitis. Infants who receive a probiotic product have a risk of potentially having a fatal disease or infection due to bacteria or yeast in the product, the letter says.[1]

State of emergency declared in New York due to lack of infant formula

On May 22, 2022 New York , Mayor Eric Adams signed a decree imposing a state of emergency in the city due to a shortage of infant formula after the closure Abbott of the Nutrition plant. A nationwide shortage of infant formula is forcing parents and families to look for supplies, while store shelves are emptying and communities are resorting to levies to redistribute available supplies.

The deficit is estimated at 50% of the needs of the American market. The problem arose after the closure of the production line of Abbott Nutrition, one of the largest suppliers of infant formula in the United States, pathogenic bacteria were found in them.

State of emergency declared in New York due to lack of infant formula

The decree will be valid for 30 days, the law was passed on May 22, 2022, due to the fact that almost half of all retail stores in the three states USA faced a shortage of milk mixtures, according to to data the mayor's office. This is stated in a statement on the website of the city of New York.

New York City Mayor Eric Adams said New York will now send teams from the U.S. Department of Consumer Protection and workers to stores across the city to check dairy prices. Adams added that the emergency order is only the first quick action, and that his staff is developing a strategy for how the city can do more to protect the city's parents.

In mid-May 2022, the president Joe Biden invoked the Defense Production Act to prioritize the delivery of milk formula ingredients to manufacturers. Biden also launched Operation Flying Formula, in which the first batches of dairy formula from abroad were delivered on May 21-22, 2022. On May 25, White House spokeswoman Karin Jean-Pierre announced that US military transport aircraft had begun an emergency import United States Europe into newborn milk formula.^[2]

Recall of mixtures due to bacterial infections in children

On February 18, 2022, Abbott Laboratories said it was recalling three types of infant formula following consumer complaints of bacterial contamination that could cause severe illness in infants.

The U.S. Food and Drug Administration (FDA) is investigating complaints about four cases of infant disease in Minnesota, Ohio and Texas related to exposure to the cronobacteria and salmonella. All four babies were hospitalized, one died. Bacteria in the Cronobacter family are believed to have contributed to this death, the authority said.

Abbott recalls popular dairy formula due to bacterial infections in children

The recall includes separate batches of Similac, Alimentum and EleCare blends that were produced at Abbott's facility in Sturgis, Michigan. The recall comes after the FDA received four consumer complaints about bacterial infections related to these mixtures.

Three complaints involved Cronobacter sakazakii, a bacterium that can cause severe, life-threatening infections or inflammation of membranes that protect the brain and spine. Cronobacter infection can also cause intestinal damage and spread through blood to other parts of the body, according to the FDA.

We appreciate parents' trust in us regarding high-quality and safe food and will do everything necessary to maintain that trust and resolve this situation, "said Vicky Assardo, senior director of communications at Abbott Nutrition.

The recall affects certain batches of Similac, Alimentum and EleCare with an expiration date of April 1, 2022 and beyond. The recall does not apply to Abbott products made at other facilities, the company said. In its statement, the company did not specify how many units of products affected the recall.

Abbott said that when checking the Sturgis facility, she "found signs of Cronobacter sakazakii at the plant in areas not in contact with products," but found no signs of Salmonella Newport, the bacterium mentioned in the fourth consumer complaint.

None of the products distributed tested positive for these bacteria, Abbott said.

The FDA said it inspected the site at a plant where environmental samples tested positive for Cronobacter. Inspectors also identified potential production problems, and an analysis of internal records showed the company had destroyed products in the past due to bacterial contamination, the agency said.^[3]

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