Similac Formula Contaminated at Plant Where FDA Found Abbott Failed to Maintain Sanitary Conditions, Procedures

Poor quality control issues at a Michigan production plant may have contributed to Similac contamination which led to a massive baby formula recall last month.

Following nationwide reports of infant illnesses from to contaminated Similac formula that was recalled last month, federal regulators have released a number of recent inspection reports, highlighting serious quality control problems at the Michigan facility where the formula was made.

On February 17, Abbott Laboratories issued a massive baby formula recall impacting certain versions of Similac, Alimentum and EleCare, after acknowledging that products may contain Salmonella Newport and Cronobacter sakazakii bacteria.

Within days, reports began to surface that suggested the company knew about the Similac contamination problems at its facility since at least September 2021, when the Minnesota Department of Health began investigating a case involving an infant infected with Cronobacter. Two U.S. Senators have already launched an inquiry, asking why Abbott delayed issuing a recall or warning parents, and a number of Similac recall lawsuits have been filed by parents of babies who suffered injuries.

This week, the FDA released inspection reports from September 2019, September 2021 and January through March 2022, which describe issues with quality control and sanitization procedures at the plant that date back even further.

The FDA inspections found that Abbott failed to establish a system of process controls to be certain its infant formula products did not have microbial contamination. It also failed to ensure surfaces that come into contact with its formula products were free of contamination as well.

“Once the immediate public health risk is minimized, FDA will conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints, illnesses and recalls,” the agency’s investigation update states. “Conducting this review is a top priority for the FDA and will be done as efficiently as possible, and we can ensure this effort will not interfere with the immediate recall response activities. We will and must continue focusing on taking all steps possible to protect the health of those who rely on safe powdered infant formula.”

Similac Formula NEC Concerns

The intense scrutiny comes at a time when Abbott was already faces a rapidly growing number of necrotizing enterocolitis (NEC) lawsuits brought by families of premature infants diagnosed with a devastating gastrointestinal disorder after being fed the company’s cow milk formula in the NICU.

Those families allege that Abbott has known for years that Similac formula posed serious risks for premature infants, yet continued to market and promote its products for use among preemies and low-birth weight infants.

NEC from Similac can cause severe intestinal perforations, infections and the need for emergency surgery, often resulting in death for the infant. However, families indicate that their premature baby may have been spared if accurate warnings and information had been provided about the benefits of using breast milk or donor milk, instead of formula.

Later this month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to hear oral arguments on a motion filed by Abbott to centralize and consolidate all Similac NEC lawsuits and Enfamil NEC lawsuits before one federal judge, for coordinated discovery and pretrial proceedings.

However, since that motion was first filed, dozens of Similac recall lawsuits have now been against the company, alleging that it knew Similac was causing Salmonella and other injuries, yet failed to warn families.