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Why Were Baby Formula Recalls So Delayed?

The arrival of a new baby changes your life forever. Choosing between breast milk and baby formula is just one of the countless tough decisions ahead of you. If you decide to go with formula, there are some safety risks you’ll need to keep in mind.

Powdered Baby Formula Recall

On February 17, Abbott Nutrition issued a baby formula voluntary recall of Similac, EleCare and Alimentum powdered formulas after consumers reported to the CDC and FDA that the products were making their infants sick. The affected formulas were produced at a single Abbott facility in Sturgis, Michigan.

Similac baby formula on kitchen counter

Four infants who consumed the formula developed bacterial infections, and two of them tragically passed away. The type of bacteria, called cronobacter sakazakii, can cause life-threatening conditions that are especially dangerous in infants. These include sepsis – when an already-existing infection rapidly spreads to the rest of the body – and meningitis, or swelling of the protective membranes around the brain and spinal cord. Meningitis in newborns is rare but can be fatal if not treated immediately. Premature infants born before 37 weeks, too weak to fight off infections, are most at-risk. Infants less than two months old are more likely to develop meningitis after being exposed to Cronobacter bacteria.

The first symptom of Cronobacter infection is a fever. Feverish infants may feed poorly, cry more than usual or have low energy. If you observe these symptoms in your baby, seek immediate medical attention.

Each year, two to four cases of Cronobacter sakazakii bacterial infection are reported to the CDC. But because most laboratories and hospitals aren’t required to report them, the actual number may be much higher.

Delays in Baby Formula Recalls

While Abbott did not issue the recall until February, FDA inspectors found unsanitary conditions at the Michigan plant in September 2021, five months earlier. Minnesota health officials told them about one of the Cronobacter-infected babies that same day. A January FDA inspection found Cronobacter on machinery, doors and the floor in the facility. Why did Abbott wait so long to recall the formula when they knew infant lives were at risk? 

Abbott’s recall stated that while they perform routine quality checks on their powdered and liquid infant formulas, their most recent check before the recall did detect Cronobacter bacteria in areas separate from where the formula is produced. None of their pre-distribution testing on the final product found the bacteria. 

Nearly two weeks later, on February 28, the FDA and CDC determined that another infant was fatally infected with Cronobacter after consuming Similac PM 60/40 powdered formula. Five samples taken at the Michigan facility, four by the FDA and one by Abbott, tested positive for Cornonbacter. Each positive test was a different strain of the bacteria. Product testing samples collected and analyzed by the FDA came back negative. 

Following another inspection on March 18, the FDA issued a Form 483 to the Sturgis facility. It stated that the plant failed to establish a system of controls adequate enough to detect contamination and listed various processes designed to improve detection. No further action has been taken at this time. 

The CDC completed its own additional testing of two samples, one taken from patients and the other from the facility. The patient samples did not genetically match those from the plant. The FDA is continuing to work with Abbott Nutrition on a safe return to production. 

Related: NEC Baby Formula Lawsuits

Bacterial infections are difficult to treat and can be fatal if treatment is delayed or not given. When your baby is in danger, every second counts. Infant formula manufacturers play a vital part in providing the nutrition babies need to grow strong and healthy. Babies cannot tell you that something is wrong; you must keep a watchful eye and advocate on their behalf. If your child gets sick after consuming infected formula, there are legal channels to help you bring justice to those responsible.