Abbott’s infant formula contaminated with Cronobacter sakazakii and Salmonella is recalled worldwide
FDA recall of Abbott’s infant formula in the US
On February 17, 2022, the FDA announced that it is investigating four consumer complaints of infant illness- related to products from Abbott Nutrition’s Sturgis, MI facility. The FDA received consumer complaints from 9/6/2021 to 12/18/2021. All cases reported about infants who had consumed powdered infant formula produced by Abbott Nutrition’s Sturgis, MI facility.
These complaints include three reports of Cronobacter sakazakii infections and one of Salmonella Newport infection of infants. All four cases related to these complaints were hospitalized, and the Cronobacter may have contributed to a death in one case. A total of 4 adverse events (3 Cronobacter, 1 Salmonella), in three states (MN (1), OH (1), and TX (2)). All affected infants were hospitalized. One death has been reported but has not been confirmed as solely attributable to Cronobacter infection.
The FDA found several positive Cronobacter results from environmental samples. As a result, Abbott initiated a voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan. During testing in the facility, the company found Cronobacter sakazakii in non-product contact areas of the plant. The company found no evidence of Salmonella Newport. Products made at the Sturgis facility were distributed across the United States and were likely exported to other countries.
CFIA recall of Abbott’s infant formula in Canada
On the same day of the FDA notice, the CFIA announce their own recall of the Abbott infant formula due to possible Cronobacter sakazakii and Salmonella contamination in Canada. There have been no reported illnesses associated with the consumption of these products in Canada. The recalled products have been sold nationally.
Abbott recall notice
On February 17, 2022, Abbott posted the recall notice on its website. Abbott reported that the recall of powder formulas included the brands of Similac®, Alimentum ®, and EleCare®, manufactured at the Sturgis Michigan plant.
The announcement emphasizes that the recall is from a single plant in Sturgis, MI, and does not include any metabolic deficiency nutrition formulas.
Abbott highlight that, as part of their quality processes, they conduct routine testing for Cronobacter sakazakii and other pathogens in the manufacturing facilities. The company found evidence of Cronobacter sakazakii during testing the Sturgis Michigan facility, in the plant in non-product contact areas. However, they did not find Salmonella Newport. Their notice emphasizes that all finished products are tested for Cronobacter sakazakii, Salmonella Newport, and other pathogens, and that they must test negative before any product is released. Retained samples related to the three complaints tested negative for the organisms.
History of the FDA’s inspections of the Michigan Sturgis plant
The Abbott’s infant formula production facility in Sturgis, Michigan, had undergone twenty-seven FDA inspections from October 2008 to December 2021. In 24 of 27 FDA inspections, the company’s operations received no citation. In September of 2019 the FDA noticed that the company did not test infant formula produced before distribution as required for microbiological quality.
However, in the FDA’s inspection of September 2021, there were few citations, including the lack of sanitary conditions in the building used in the manufacturing processing, packing, and holding of infant formula. Abbott acknowledged that Cronobacter sakazakii was found in non-product contact areas in the plant.
Infant formula recalled around the world
Since Abbott is a major international company, the recalled products had a very wide worldwide distribution. The products were distributed in addition to the US and Canada, to Australia, Bahrain, Barbados, Bermuda, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam ANI South.
Even countries that did not get the Abbott products directly warned customers not to use certain Abbott infant formula. For example, China Customs has warned consumers against buying and cosuming certain infants and babies products of Abbott Laboratories that were affected in a recent recall linked to a U.S. factory. China Customs said that while the affected formula products were not directly sold in China, some consumers who may have bought them from abroad via cross-border e-commerce should stop using them.
The history of Cronobacter sakazakii
Cronobacter has an interesting history. John J. Farmer in Front. Pediatr., November 27 2015 presented a great review. While Cronobacter was the suspected cause of meningitis in infants in the early 1960s, it took until 1980 to prove it. Initially the organism was called Enterobacter sakazakii
In 1983 eight neonatal meningitis and sepsis cases of Enterobacter sakazakii were reported from the Netherlands. This was the first large series of neonatal infections to be reported and the first outbreak with a thorough analysis.
In 1987 an article was published on the contamination rate of commercial powdered formula products, produced in 35 different countries. They found E. sakazakii and other Enterobacteriaceae to be common contaminants. The article marks the beginning of the connection between E. sakazakii with powdered formula. This association and the danger of contaminated powdered formula were emphasized.
In 1988 the first documented E. sakazakii outbreak in the United States was presented. The death of an eleven-day-old infant in 2001 in a neonatal intensive care unit of a Tennessee hospital was traced to the use of Portagen powdered infant formula manufactured by Mead Johnson. Nine out of 48 infants in the hospital tested positive for Cronobacter.
In 2001 Cronobacter became a new genus to include the formerly classified as Enterobacter sakazakii.
Cronobacter sakazakii is commonly found in the environment. This opportunistic bacterium survives in dry, low, moisture environments, such as infant formula. According to the CDC Cronobacter infections are rare but can be deadly in newborns. Infections in infants usually occur in the first days or weeks of life. About two to four cases are reported to CDC every year. Still, this figure may not reflect the actual number of illnesses since most hospitals and laboratories are not required to report Cronobacter infections to health departments.
Finally
Several months have elapsed since the consumer complained until the recall. It should be investigate how the recall process can become more effective.
Abbott is a reputable company with a sound quality system. How come that after discovering Cronobacter sakazakii in the factory environment, the company did not take action to eradicate the organism? In its inspection of September 2019, the FDA mentioned the lack of sufficient microbiological tests of infant formula finished products to meet the required microbiological quality.
Even though there are currently only four original infants complains, they still caused the recall of an enormous amount of product and caused shortage of some infant formula in the US market.