Similac Formula Manufacturing Problems Reported to FDA 15 Months Before Massive Recall

Government oversight report calls for stronger FDA authority and training to respond to infant formula manufacturing problems in the future.

The U.S. Food and Drug Administration (FDA) sat on information about serious manufacturing problems at a Similac infant formula plant for more than year, due to “inadequate policies and procedures”, according to a new federal investigation.

In February 2022, the FDA announced an Alimentum, Elecare and Similac formula recall, following the discovery that powdered infant formula products manufactured at a Michigan facility were contaminated with Salmonella Newport and Cronobacter sakazakii bacteria. The contamination resulted in a widespread outbreak of infant infections, which killed at least two children and led to hundreds of illnesses nationwide.

An investigation by the FDA found that Abbott Laboratories, the manufacturer, ignored safety standards and best practices at its facility for years, and dozens of families are now pursing Similac recall lawsuits , claiming the company endangered children for the sake of profits.

However, a report (PDF) released this month by the Department of Health and Human Services’ Office of Inspector General (OIG) found significant failings in how the FDA responded to problems at the facility as well.


Was your premature child fed Similac or Enfamil?

Premature infants fed Similac or Enfamil cow's milk formula face an increased risk of necrotizing enterocolitis (NEC) or wrongful death.


The report indicates that the FDA received a whistleblower complaint about conditions at the Michigan facility 15 months before pushing for a recall. However, the warning was accidentally archived instead of being acted upon, the OIG found.

“FDA had inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes, the OIG report states. “For example, FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints in an efficient and effective manner and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. In addition, FDA did not escalate an October 2021 whistleblower complaint to senior leadership, resulting in a nearly 4-month delay before senior leadership was aware of the complaint.”

Other failings noted by the OIG report indicate that the FDA lacked the authority to require adequate reporting from infant formula manufacturers that would have helped the agency identify and respond to manufacturing problems quickly, and that manufacturers are not required to notify the agency of undistributed infant formula products that tested positive for pathogens.

The OIG provided the FDA with a list of recommendations aimed at preventing future outbreaks, calling for more training on whistleblower policies, improved procedures on performing mission-critical inspections in a timely manner, and new policies strengthening the FDA’s use of its infant formula recall authority.

June 2024 Similac Recall Update

More than 80 Similac food poisoning lawsuits have been filed by parents of children diagnosed with various injuries after consuming the recalled infant formula, alleging that Abbott Laboratories neglected safety standards for profit.

Given common allegations raised in complaints being pursued throughout the federal court system, all lawsuits over the Similac recall have been centralized before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

To help the parties evaluate the strengths and weaknesses of claims, Judge Kennelly has established a Similac lawsuit bellwether trial process, where the parties are focusing on preparing a small number of representative claims to go before juries.

While the outcome of these bellwether trials will not be binding on other cases, they will likely have a big impact on the average Similac recall settlement amounts the manufacturer may have to pay to avoid dozens of individual claims being set for trial in the coming years.


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