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Abbott Laboratories Settled False Claims Allegations

The company has agreed to pay $385 million to resolve claims regarding infant formula safety and testing practices.

Updated on Oct. 11, 2026 in Babies

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Abbott Laboratories agreed to a $385 million settlement to resolve allegations that it provided false information regarding infant formula safety standards and sanitation practices. AI Illustration. Upload story photo >

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Abbott Laboratories will pay $385 million to settle allegations that it submitted false claims for infant formula manufactured under unsafe conditions. The settlement covers the company's production facilities in Sturgis, Michigan, and Casa Grande, Arizona.

Why it matters

The government alleged the manufacturer intentionally bypassed bacterial testing and ignored sanitation risks to increase production output. This settlement addresses claims that the company failed to meet safety standards for essential infant products.

Abbott will pay $348,700,868 to the U.S. government and $36,298,172 to certain states to resolve allegations spanning from 2018 to 2022. The settlement follows a whistleblower lawsuit filed in October 2022.

The players

Abbott Laboratories

This global medical device and healthcare company is headquartered in Abbott Park, Illinois.

U.S. Food and Drug Administration

This federal agency is responsible for protecting public health by ensuring the safety and efficacy of food and drug products.

The details

The allegations centered on Abbott using temporary leak mitigation to divert water in processing areas while running dryer equipment beyond established cleaning cycles. The company was also accused of withholding test results for bacterial growth from the FDA during the investigation period.

Timeline

  1. The alleged false claims occurred between January 1, 2018, and December 31, 2022.

  2. Abbott voluntarily recalled certain powdered infant formulas on February 17, 2022.

  3. The Sturgis manufacturing facility resumed operations in June 2022.

  4. Whistleblowers initiated a lawsuit in October 2022 in the Western District of Michigan.

  5. The federal government officially joined the lawsuit against Abbott on November 13, 2022.

Culture Shift

This settlement highlights a broader trend of increased regulatory scrutiny regarding the production of essential infant nutrition. It marks a significant moment in holding major manufacturers accountable for internal safety oversights that prioritize production volume over consumer health.

Parents and caregivers may experience changes in how infant formula products are scrutinized for quality assurance and safety transparency. The outcome serves as a reminder to monitor current recall notices and FDA safety communications for household goods.

The takeaway

This case underscores the importance of stringent sanitation practices in the production of vulnerable-population nutrition. Consumers are encouraged to verify the latest safety guidelines from federal health agencies when making dietary decisions for infants.

Further reading

Learn more about the latest industry standards by visiting our Babies section.

Source note: This article includes information reported by Lake and McHenry County Scanner.

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Should food manufacturers be held strictly liable for contamination in their facilities, regardless of findings?