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A New Baby Formula Recall Issued Due to Bacteria Concerns

Many parents and caregivers depend on powdered baby formula to feed their children. Some do not have access to breastmilk, the nourishment pediatricians recommend as the number one way to feed newborns. In recent years, however, parents have not always been able to rely on manufacturers to provide safe or accessible baby formula products.

There have been times when brands have suddenly undergone a safety recall, leaving parents scrambling to find formula or, even worse, causing stores to run out of products. Others have experienced frustration over purchasing specialty formulas, thinking it was safe to feed their baby who could not drink traditional baby formula, only to learn they were misled by what the formula contained.

Scientist holding agar plate for diagnosis bacterial or microorganism,microscope in background at laboratory.

Most recently, another powdered baby formula recall was announced by the Food and Drug Administration (FDA) on Dec. 31. Reckitt/Mead Johnson Nutrition voluntarily recalled 675,030 cans of Nutramigen Hypoallergenic Infant Formula, a product made for babies who are allergic to cow’s milk. It was produced at its plant in Zeeland, Michigan.

The manufacturer recalled the formula due to Cronobacter sakazakii contamination found in cans imported into Israel from the U.S. There were no reports of illness at the time of the FDA announcement.

Cronobacter sakazakii can cause life-threatening infections, including sepsis or meningitis. Symptoms include irritability, temperature changes, jaundice, grunting breaths, and abnormal movements. The infection may also cause bowel damage and spread through the blood to other parts of the body.

The FDA first became aware that the formula produced at the Mead Johnson facility had tested positive for the bacteria on Dec.14, 2023. Still, the initial test alone did not warrant an FDA recall. 

However, on Dec. 28, after Israeli health officials confirmed Cronobacter sakazakii in further testing, the FDA immediately contacted Mead Johnson Nutrition and recommended they begin recalling the formula, distributed in June, July, and August of 2023 at retail stores across the country. 

While the FDA did not receive any reports of illness in connection with Cronobacter sakazakii and the recalled Nutramigen, it is “likely most of the product that was distributed in the U.S. has already been consumed,’’ the announcement said.

History of Cronobacter Sakazakii in Baby Formulas

Cronobacter sakazakii in baby formula has been a concern for the FDA before this latest recall.

In February of 2022, the FDA received several reports of children becoming sick after being given formula manufactured by Abbott Nutrition from a plant in Sturgis, Michigan. This resulted in a voluntary recall for formulas under the Similac, Alimentum, and EleCare brands. At the same time, the Sturgis facility was also temporarily closed. 

This recall came when the COVID-19 pandemic was in full swing. While Americans were dealing with supply chain issues brought on by the pandemic, the Abbott recall added even more stress to a situation where parents faced the prospect of being unable to find the proper nutrition for their infants. 

Manufacturing Safe Infant Formula Free of Bacteria

Because of the severity of the baby formula issue in 2022, the FDA created a Cronobacter prevention strategy “to improve oversight of safe production of powdered infant formula.” The plan included improving oversight of production, broadening scientific knowledge, and enhancing communication. In a letter to manufacturers and distributors, the FDA called on the baby formula industry “to take prompt action to improve processes and programs.” Despite the new strategy, the bacteria still surfaced in the formula inspected at the Israeli border made at the Michigan plant. 

In its December 2023 recall announcement concerning Cronobacter sakazakii in the formula, the FDA acknowledged the original strategy set in 2022. The agency also stressed that when it comes to protecting the “most vulnerable population,’’ the FDA remains committed to ensuring “an adequate supply of infant formula and giving consumers the utmost confidence that infant formula is available in the U.S. is safe and nutritious.”

NEC Baby Formula Lawsuits Uncover Other Baby Formula Issues 

In the most recent December 2023 recall, the FDA noted it was in communication with other manufacturers to request their assistance “in ensuring a robust supply of hypoallergenic product.”

While the announcement held assurance for some, many new parents are already on edge concerning specialty formulas, specifically those for babies born prematurely. 

Parents have become aware of a devastating issue concerning cow’s milk-based formulas for premature babies that have been linked to necrotizing enterocolitis (NEC). The formulas are made by both Mead Johnson and Abbott Laboratories. NEC baby formula lawsuits were filed against the two manufacturers after premature babies who were fed the formula became severely sick (some even died) from NEC. 

Necrotizing enterocolitis is an inflammatory disease infecting intestinal tissues that affects one in 1,000 preemies, with a mortality rate of up to 50 percent. For years, it has been known that premature babies are susceptible to NEC, as well as the fact that cow’s milk-based formulas are often difficult for babies to digest.

NEC baby formula lawsuits can hold manufacturers responsible for not adequately warning parents or doctors of the risks associated with these types of baby formulas.

Baby Formula Legal Options

When a parent believes their infant has suffered an illness due to a powdered baby formula, the first step should be to immediately seek medical treatment for the baby. They should also consider contacting a lawyer experienced in baby formula lawsuits. The lawyer you choose should offer a free consultation so they can review your case and determine the best path forward.

Parents of premature babies who developed NEC after consuming cow’s milk-based powdered formula have the right to pursue an NEC baby formula lawsuit, possibly as part of a mass tort product liability claim.

Regardless of whether formula manufacturers acted maliciously or not, when a child is injured, those who are responsible should be held accountable.