Abbott Recalls Infant Formula Made At Facility FDA Is Investigating For Bacterial Contamination
Executive Summary
Abbott Labs recalls Similac, Alimentum and EleCare brand formula powders made at Sturgis, MI, plant. FDA says complaints about Abbott’s formulas included three reports of Cronobacter sakazakii infections, with one death potentially linked, and one of Salmonella Newport infection.
The Food and Drug Administration is inspecting Abbott Laboratories Ltd's Sturgis, MI, facility after four consumers complained about infants’ illnesses, including potentially one death, after consuming powdered infant formula produced there.
Minutes before the agency announced the complaints and its inspection on 17 February, the firm's Abbott Nutrition business announced it is recalling Similac, Alimentum and EleCare brand formula powders made at the Sturgis plant. The products made at the Sturgis facility and subject to the recall were distributed across the US and likely exported to other countries.
The FDA, which noted it is working on the investigation with the Centers for Disease Control and Prevention and state and local agencies, said the complaints about the Abbott formulas included three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants.
All four infants linked to the complaints, received between 6 September and 18 December 2021, were hospitalized; one of the infants died potentially due to Cronobacter, the FDA says.
Findings from the ongoing facility inspection include “several positive Cronobacter results from environmental samples taken by FDA” and “adverse inspectional observations” by its investigators. A review of Abbott’s records also indicate finding environmental contamination with Cronobacter sakazakii and destroying products due to the presence of the bacteria, says the FDA.
Abbott stated that during routine testing for Cronobacter sakazakii and other pathogens at Sturgis, as it does in its other manufacturing facilities, it found evidence of Cronobacter sakazakii in non-product contact areas. It found no evidence of Salmonella Newport.
Retained Samples Tested Negative
The Abbott Park, IL-based firm also says its retained samples tested negative for Cronobacter sakazakii and for Salmonella Newport. It continues to test at the facility and “no distributed product has tested positive for the presence of either of these bacteria.”
Pediatric Nutrition Sales Strong For Abbott
Abbott, which also markets infant and adult nutritional beverages, reported in January that its worldwide pediatric product sales during the fourth quarter increased 3.1%, on reported and organic metrics, to $1.04bn.
It noted “continued share growth in infant nutrition” in the US led to 14.5% pediatric nutrition sales growth to $507m.
International sales of pediatric formulas and other nutritional products during the October-December period were down 8% from the prior-year quarter at $469m, according to Abbott’s release.
Full-year sales for its pediatric nutrition business reached $4.3bn on 4.2% growth, with US sales up 10.2% to $10.3bn as international sales slipped 1.5% to $2.1bn.
Its quality checks on each completed batch of infant formula, including microbiological analysis prior to release, include tests for Cronobacter sakazakii, Salmonella Newport and other pathogens. No Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall.
The FDA explained the recall covers the Abbott brands packaged in containers printed with codes with 22 through 37 as the first two digits and containing K8, SH, or Z2 and with expiration dates of 1 Aprill 2022 or later.
Similac is Abbott’s largest infant formula brand, and includes the Alimentum hypo-allergenic formulation; EleCare, a separate brand, is an amino acid formula.
Previous Abbott recalls of infant formula products listed in FDA records were linked to labeling errors, ready-to-use products containing water and improper sealing of containers, such as a 2006 recall of Similac formulations. (Also see "Abbott recalls infant formula" - HBW Insight, 25 Sep, 2006.)
The problems reported with Abbott’s formulas surface as the FDA’s Center for Food Safety and Applied Nutrition continues its “Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages” initiative in April 2021 following widespread reports of contamination of baby food products, though not infant formula. (Also see "US FDA ‘Closer To Zero’ Meeting On Infant Nutrition Safety And Benefits Set For November" - HBW Insight, 8 Oct, 2021.)
While infant formula wasn’t among the categories of baby nutrition products found contaminated with heavy metals in 2021, the agency is quick to announce consumer alerts or industry instructions or suggestions when problems with infant formula emerge. The FDA’s budget request for fiscal year 2022 published in May asked Congress to allow it to require infant formula to advise it when they anticipate shortages in supplies. (Also see "Requiring Infant Formula, Medical Food Shortage Updates Included In US FDA Budget Request" - HBW Insight, 30 May, 2021.)