There has been no recall as of 2022. The Food and Drug Administration (FDA) has not recalled Enfamil baby formula despite its packaging lacking any warning label about the increased risk of NEC cases.
Enfamil infant formula products including Premature, NeuroPro, and Human Milk Fortifier remain available today.
An alternative to Enfamil is Prolacta, a human milk-based fortifier that has been available since 2006, and a ready-to-feed formula that has been available since 2014. Pasteurized human donor milk is available through the Human Milk Banking Association of North America and the European Milk Bank Association.
As of January 2022, there are 33 lawsuits against Enfamil maker Mead Johnson & Company (as well as Similac Special Care maker Abbott Laboratories, Inc.) in Illinois – where both companies are headquartered. They all allege that the cow’s milk-based formula caused NEC in preemies. Thousands more lawsuits are expected.
Of the 480,000 preterm infants born in the U.S. annually, about 9,000 develop cases of NEC. And 90% of those cases occur in preemies; 10% occur in full-term infants.