Enfamil Nutramigen Recall Issued For Hypoallergenic Infant Formula Powder Contaminated With Cronobacter sakazakii

The recalled infant formula was distributed just a month before the FDA sent a warning letter to Enfamil manufacturer, criticizing its sanitation and quality control procedures, which may expose babies to serious infection risks

More than 650,000 cans of Enfamil Nutramigen are being recalled, due to a risk that the hypoallergenic infant formula powder may be contaminted with cronobacter sakazakii bacteria, which can cause babies to develop serious and potentially life-threatening infections.

The Enfamil Nutramigen powder recall was announced by Reckitt/Mead Johnson Nutrition on December 30, after the detection of Cronobacter sakazakii in products sampled outside of the U.S.

Cronobacter sakazakii in infant formula has been linked to widespread illnesses following contamination problems at an Abbott Laboratories Similac manufacturing plant in 2022. However, officials indicate that no illnesses or injuries have been reported in connection with the Enfamil recall for Nutramigen formula, which is a specialty product designed for infants with Cows Milk Allergy.

Similar contamination problems led to a massive recall for Similac, Alimentum and EleCare formula manufactured by Abbott Laboratories prior to February 2022, and nearly 100 Similac recall lawsuits have been filed throughout the federal court system, each alleging that Abbott ignored industry safety standards and best practices at its facility for years, endangering infants for the sake of profits.

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

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Infant Formula Cronobacter Risks

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.

Disease-causing bacteria such as Cronobacter can be extremely dangerous when consumed by infants, especially for low birth weight and preterm infants.

While rare, infant Cronobacter sakazakiiis infections may cause sepsis or make the linings surrounding the brain and spinal cord swell, known as meningitis. Such infections in infants typically present symptoms of fever, bowel damage, temperature change and poor feeding which can result in failure to thrive, causing them to be smaller or shorter than other children the same age.

Enfamil was one of three infant formula manufacturers to receive warning letters from the U.S. Food and Drug Administration (FDA) in August. The other two were Gerber and ByHeart.

The FDA indicated that inspections conducted at the facilities identified several violations of the Federal Food, Drug, and Cosmetic Act, as well as the FDA’s infant formula regulations. The latest recalled batches of Nutramigen were manufactured a month before those FDA warning letters were sent out.

Nutramigen Powder Recall

The recall affects six batches of Nutramigen sold in 12.6 ounce containers with batch codes ZL3FHG, ZL3FMH, ZL3FPE, ZL3FQD, and ZXL3FXJ. It also affects 19.8 ounce cans with batch code ZL3FRW. All of the affected products have a UPC code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

An estimated 657,000 cans are affected. The recalled infant formula was manufactured in June 2023 and distributed in June, July and August of last year. The manufacturer claims it is likely most of the affected products have already been consumed.

The manufacturer recommends consumers check the bottom of Nutramigen cans to identify the batch number and dispose of affected products or contact the manufacturer for a refund. Consumers can call 866-534-9986 or email consumer.relations@rb.com for more information.

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