Enfamil ProSobee Recall Issued For Plant-Based Infant Formula Cronobacter Poisoning Risk

Cronobacter contamination led to a major Similac recall almost exactly a year ago, which was linked to a number of infant illnesses and deaths.

Nearly 150,000 cans of Enfamil Prosobee plant-based infant formula have been recalled, due to concerns they may be contaminated with Cronobacter sakazakii, a bacterial contaminant that can cause severe illness or deaths among babies.

The U.S. Food and Drug Administration (FDA) announced the Enfamil Prosobee recall on February 20, after the manufacturer, Reckitt, warned that there may be cross-contamination with Cronobacter, which is the same bacteria that led to a Similac recall last year.

To date, the manufacturer indicates the products have tested negative for the contaminants and no illnesses have been reported. However, contaminated Similac, Alimentum and EleCare infant formula recalled last year by a different manufacturer were linked to hundreds of reports involving Cronobacter poisoning, including severe cases that resulted in hospitalization or death, highlighting the serious risks posed by contaminated formula.

Cronobacter sakazakii is a rare type of bacteria, often found in dry foods, such as infant formula, skimmed milk powder, tea and starches. The bacteria exists in the environment and can survive in very dry conditions, making transmission of the infection possible by touching contaminated surfaces.

The infections can be particularly deadly for infants and the elderly, or those with weakened immune systems. The bacteria may cause serious life-threatening infections or meningitis (an inflammation of the membranes that protect the brain and spine).

The Enfamil ProSobee recall affects about 145,000 cans from two batches of the Simply Plant-Based Infant Formula sold in 12.9 oz containers, which were manufactured between August 2022 and September 2022, with batch numbers ZL2HZF and ZL2HZZ and a UPC Code of 300871214415. The recalled cans have a “Use By Date” of 1 Mar 2024.

Consumers who purchased the recalled Enfamil Prosobee formula are urged to dispose of them or return the cans to the place of purchase for a total refund. However, lawyers recommend that families of infants who may have developed Cronobacter food poisoning from Enfamil Prosobee should preserve the formula in a way to prevent any further consumption, but allow future testing if they are considering an infant formula lawsuit.

Infant Formula Contamination Lawsuits

The recall comes as Abbott Laboratories continues to face hundreds of infant formula recall lawsuits over similar problems discovered with Similac, Alimentum and EleCare formula products last year, which were recalled in February 2022, resulting in widespread shortages nationwide.

Following that 2022 recall, investigations have revealed that Abbott Laboratories ignored industry safety standards and best practices at its facility for years, endangering children for the sake of profits, leading to individual and class action lawsuits filed throughout the federal court system.

After the Abbott formula recall, the FDA faced sharp criticism for failing to prevent the widespread distribution of contaminated formula for months, as reports suggested that the manufacturer and regulators were aware of cronobacter infections for months before the recall was issued for Similac, Alimentum and EleCare.

In the wake of the recall, the FDA outlined new strategies to prevent Cronobacter contamination of infant formula.

Necrotizing Enterocolitis (NEC) Lawsuits Over Similac and Enfamil

Concerns about Abbott’s handling of contaminated baby formula came as the company was already facing hundreds of necrotizing enterocolitis (NEC) lawsuits filed by parents of premature infants who developed a devastating gastrointestinal condition after they were fed the cow’s milk formula in the hospital or NICU, emerging that the company has placed its desire for profits before the safety of infants for decades.

That litigation emerged following studies that found premature infants face a substantially greater risk of developing NEC after they are fed Similac, Enfamil or other cow’s milk-based formula products, as opposed to a mother’s breast milk, donor milk or human milk formula products.

Although there is evidence that the makers of cow’s milk-based versions of Similac and Enfamil have known for years about the NEC risks for premature infants, the companies continued to aggressively market their products to hospitals and parents of newborns, including versions of their formulas specifically intended for premature infants. As more information has come out about the risk, the company has also engaged in abusive and aggressive legal tactics in response to early NEC lawsuits, including threats to lawyers advertising to raise awareness among families about the potential for a settlement.