Baby formula shortages have been a concerning trend in the last few years. A major reason for the shortages may be contamination in baby formula manufactured by Abbott Laboratories, which controls roughly 40% of the baby food market. Now, the FDA and U.S. Attorney’s Office are both investigating the company, according to Top Class Actions.

Abbott Laboratories has recalled multiple brands of infant formula since Feb. 2022, including Similac, Alimentum, EleCare, and Pedialyte Electrolyte Solution. All of the recalled products were manufactured in Sturgis, Michigan. 

According to the FDA, failures on the part of Abbott Laboratories were a “major contributing factor” to the nationwide infant formula shortage. The agency shut down the Sturgis manufacturing plant after it was determined that Abbott Laboratories had failed to maintain sanitary conditions at the facility. These sanitation failures have contributed to the potential contamination of the formula with pathogens including Salmonella, Clostridium botulinum, and Cronobacter sakazakii. 

In its defense, Abbott Laboratories has maintained that none of the products it distributed tested positive for either Cronobacter or Salmonella. However, the Sturgis plant reportedly tested positive for Cronobacter sakazakii in non-product-contact areas.

According to the agency, “Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine).” While these infections are rare, they are especially risky for newborn infants. The FDA states that symptoms of Cronobacter infection can include:

  • Abnormal body movements
  • Grunting breaths
  • Irritability
  • Jaundice
  • Poor feeding
  • Temperature changes

If an infant has consumed the recalled infant formula and begins to exhibit symptoms, the FDA recommends contacting a healthcare provider for immediate care.

In addition to the FDA investigation into the contamination of infant formula, the U.S. Securities and Exchange Commission has received documentation from Abbott Laboratories that indicates the company is also facing a criminal investigation by the U.S. Attorney’s Office for the Western District of Michigan over its manufacturing practices. Documentation has also surfaced showing a civil investigative demand from the Federal Trade Commission seeking information about investigations being conducted on companies who have contracts for women, infants, and children baby formulas.

If you have been harmed by Abbott’s formula or any consumer product, you may be qualified to file a lawsuit to pursue justice.