Abbott Laboratories Settled False Claims Over Infant Formula
The company reached a $385 million settlement regarding allegations of unsanitary conditions at infant formula plants.
Updated on Oct. 11, 2026 in Babies
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Abbott Laboratories has agreed to pay $385 million to resolve False Claims Act allegations concerning products manufactured at facilities in Sturgis, Michigan, and Casa Grande, Arizona. The settlement follows federal claims that the company maintained conditions posing a risk of bacterial contamination between 2018 and 2022.
Why it matters
The settlement addresses government allegations that Abbott manufactured formula in an environment with high contamination risks and withheld test results from the FDA. This development underscores the importance of stringent safety oversight in the production of infant nutrition.
The settlement concludes a federal investigation into manufacturing practices that allegedly occurred between 2018 and 2022. While federal investigators identified four infant hospitalizations and two deaths linked to Cronobacter during the period, the scope of liability remains tied to false claims.
The players
Abbott Laboratories
A global healthcare company that develops medical devices, diagnostics, and nutritional products including infant formulas.
Food and Drug Administration
The federal agency responsible for protecting public health by regulating the safety and efficacy of food and medical products.
The details
The government alleged that Abbott used temporary umbrellas to divert water in processing areas and ran equipment past necessary cleaning cycles to boost production. Investigators claimed the company intentionally avoided bacterial growth testing and failed to report findings to the FDA. The alleged practices created an environment with a significant risk of contamination before the company initiated a voluntary recall in February 2022.
Timeline
The period of alleged false claims occurred between January 1, 2018, and December 31, 2022.
Abbott Laboratories voluntarily recalled certain powdered infant formulas on February 17, 2022.
Production resumed at the Sturgis, Michigan, plant in June 2022.
Whistleblowers filed a lawsuit in the Western District of Michigan in October 2022.
The federal government officially joined the lawsuit against Abbott on November 13, 2022.
Health Landscape
This settlement marks a significant enforcement action under the False Claims Act regarding infant nutrition manufacturing standards. It reflects a broader shift toward increased federal oversight of production environments to ensure compliance with bacterial safety protocols.
Families concerned about the history of specific formulas can verify product safety information through official recall databases and FDA alerts. Any questions regarding the nutritional needs of an infant or the safety of current feeding habits are best discussed with a pediatrician.
The takeaway
This settlement emphasizes the importance of transparency and strict adherence to sanitary standards in food manufacturing. Caregivers should maintain awareness of official FDA safety notifications and discuss any concerns about formula safety or infant nutrition with their healthcare provider.
Further reading
For more on ensuring the safety of early childhood nutrition, visit United States Babies.
Source note: This article includes information reported by Lake and McHenry County Scanner.
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