Where we are and how we got here

The current situation

On February 17, 2022, the US Food and Drug administration (FDA) advised the public that it was working with the US Centers for Disease Control and Prevention (CDC) and state and local agencies to investigate four consumer complaints of illnesses in infants.

The infants were fed powdered infant formulas manufactured by Abbott Nutrition in Sturgis, Michigan.

Three of the illnesses were due to Cronobacter sakazakii and the fourth was caused by Salmonella Newport.

The FDA received the illness reports between September 6, 2021, and December 18, 2021, from Minnesota (1), Ohio (1) and Texas (2).

All four of the infected infants were hospitalized. One of the Cronobacter-infected babies died, although it is uncertain whether the infant’s death was solely attributable to the infection.

As a result of the illness reports, the FDA initiated an inspection of the Sturgis production facility. In the course of their investigation, inspectors noted several unspecified adverse inspectional observations. In addition, several positive Cronobacter results were reported from environmental samples taken by FDA.

In response to the FDA’s findings, Abbott Nutrition has initiated a recall of multiple powdered infant formula products sold under the Similac, Alimentum and EleCare brand names. The affected products were manufactured in the Sturgis plant.

The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after.

The recalled products were distributed across the United States and may also have been exported to multiple countries around the world, including: Australia, Bahrain, Barbados, Bermuda, Canada, 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.

The recall notices

To access detailed information on the recalled products in your country, please click on the appropriate links. For countries not listed below, navigate to Abbott’s website to access additional information.

• Australia: Multiple EleCare, Similac and Alimentum products
• Canada: Multiple Similac products
• Hong Kong: None of the recalled products appear to have been distributed in Hong Kong
• New Zealand: Multiple EleCare, Similac and Alimentum products
• Singapore: Abbott Alimentum powdered infant formulas
• United Kingdom: Multiple batch codes of Elecare Similac and Alimentum Similac products
• USA and Puerto Rico: Multiple Similac, Alimentum and EleCare products

Cronobacter’s long shadow

Cronobacter was suspected to be a cause of meningitis in infants as long ago as the early 1960s.

In 1981, researchers at the Indiana University School of Medicine were able to confirm the link between Cronobacter sakazakii and a case of fatal meningitis.

In 1983, Dutch researchers were the first to suggest the connection between infant formula and Cronobacter infections. Their hypothesis was proven to be correct in a 1989 report of an Icelandic outbreak of meningitis in three newborn infants.

In 2001, the death of an eleven-day old infant in a neonatal intensive care unit (NICU) of a Tennessee hospital was traced to the use of Portagen powdered infant formula manufactured by Mead Johnson. Cronobacter was recovered from nine of forty-eight infants in the NICU.

The following year, a five-day old Belgian baby died shortly after being released from the hospital. The infant, who was infected with Cronobacter, had been fed Beba powdered formula manufactured by Nestlé.

These incidents prompted the FDA to increase its surveillance of infant formula manufacturers, with special emphasis on the possibility Cronobacter in powdered infant formulas. The agency updated its Compliance Guidance for infant formulas in 2018.

Abbott’s inspection history

Abbott’s infant formula production facility in Sturgis, Michigan, has undergone twenty-seven FDA inspections since October 2008, according to the FDA’s inspection database.

Twenty-four of the twenty-seven inspections resulted in the company’s operations receiving a clean bill of health.

In October 2010, the FDA inspector cited the company for three issues, specifically:

• Effective measures are not being taken to exclude pests from the processing areas
• There is no assurance that raw materials which are susceptible to contamination with extraneous materials comply with current FDA standards and defect action levels
• Failure to manufacture foods under conditions and controls necessary to minimize contamination.

These issues were apparently corrected, as subsequent inspections that same year and for several years did not result in any adverse reports.

The situation changed in September 2019, when the FDA inspector cited Abbott for a single issue, stating:

• You did not test a representative sample of a production aggregate of a powdered infant formula at the final product stage and before distribution to ensure that the production aggregate meets the required microbiological quality standards.

Once again, the company corrected its procedures to the FDA’s satisfaction.

There were no inspections carried out for two full years. Then, in September 2021, the FDA returned. This time, the inspection uncovered several issues:

• Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wash hands thoroughly in a handwashing facility at a suitable temperature after the hands may have become soiled or contaminated.
• You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition
• An instrument you used to measure, regulate, or control a processing parameter was not properly maintained.
• You did not monitor the temperature in a thermal processing equipment at a frequency as is necessary to maintain temperature control.
• You did not install a filter capable of retaining particles 0.5 micrometer or smaller when compressed gas is used at a product filling machine.

In its recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant in non-product contact areas,” but denied having found the bacterium in finished product.

This would appear to be in direct contradiction to the FDA’s revelation that the company had recorded the destruction of product in the past due to the presence of Cronobacter.

FDA advice to consumers

If you want to check if your powdered formula is part of the recall, you can enter the product lot code on the bottom of your package on the company’s website.

If you have questions or need information about the recall, you can Submit Questions/Get Assistance from the FDA.

If your infant is experiencing symptoms related to Cronobacter or Salmonella infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care.

To report an illness or adverse event, you can

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to FDA.

Note: Information on the history of Cronobacter infections in infants was drawn from TAINTED: From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures.

For additional information on Cronobacter, visit the CDC web page, Cronobacter infection and infants.