Enfamil and Similac NICU Formulas Named in NEC Lawsuits

Which Products Are Named in NEC Lawsuits

The NEC claims are brought against two manufacturers. Abbott Laboratories makes the Similac line. Mead Johnson & Company, a subsidiary of Reckitt, makes the Enfamil line. The claims involve cow's-milk-based formulas and fortifiers designed for premature and low-birth-weight infants, along with the transitional products used after discharge.

Two categories are involved. The first is preterm formula, which is fed to the infant directly. The second is human milk fortifier, which is a powder or liquid mixed into expressed breast milk to raise its calorie and protein content. Both categories are derived from cow's milk in the products at issue.

Mead Johnson (Enfamil) Products

Product	Type	Notes
Enfamil Premature 20 Cal, 24 Cal, 24 Cal High Protein, 30 Cal	Preterm formula	Ready-to-feed hospital formula for premature infants. The number is calories per fluid ounce, and higher numbers concentrate more calories into less volume.
Enfamil Human Milk Fortifier (powder)	Fortifier	Cow's-milk-derived powder mixed into expressed breast milk. The powder version was the standard hospital product for many years.
Enfamil Human Milk Fortifier Acidified Liquid	Fortifier	Liquid version of the fortifier, supplied in single-use vials.
Enfamil Liquid Human Milk Fortifier High Protein	Fortifier	Higher-protein liquid fortifier used for infants with greater protein needs.
Enfamil EnfaCare and NeuroPro EnfaCare (22 Cal)	Post-discharge formula	Transitional formula for infants going home from the NICU. Unlike the hospital products above, this one is also sold at retail.

Abbott (Similac) Products

Product	Type	Notes
Similac Special Care 20, 24, 24 High Protein, 30	Preterm formula	Ready-to-feed hospital formula for premature infants. Special Care 24 is the product that appears most often in these cases.
Similac Human Milk Fortifier (powder)	Fortifier	Cow's-milk-derived powder mixed into expressed breast milk.
Similac Human Milk Fortifier Concentrated Liquid and Hydrolyzed Protein Concentrated Liquid	Fortifier	Liquid fortifiers supplied in vials. The hydrolyzed protein version uses partially broken-down cow's milk protein.
Similac Liquid Protein Fortifier	Fortifier	Protein-only liquid supplement added alongside other feeds.
Similac NeoSure (22 Cal)	Post-discharge formula	Transitional formula for infants after NICU discharge. Sold at retail as well as supplied by hospitals.
Similac Alimentum	Specialty formula	Hypoallergenic formula that appears in some complaints where it was used in a NICU. It is a cow's-milk-based product with extensively hydrolyzed protein and is sold at retail.

Human Milk Fortifiers Are the Part Families Miss

Many parents describe their infant as having been fed only breast milk, and the feeding record shows something different. Fortifier is not formula in the way most people use the word. It arrives as a packet of powder or a small vial of liquid, gets mixed into expressed milk at the bedside or in the hospital's milk lab, and is charted as a nutrition order rather than as a feeding.

In the products listed above, the fortifier itself is cow's-milk-derived. That is why the NEC cases include infants whose mothers were pumping and whose milk supply was adequate. Human-milk-derived fortifiers made from donor milk exist and have been available since the mid-2000s, and whether one was used is a separate question from whether the infant received mother's milk.

The Number in the Name Is Calories per Ounce

Standard term infant formula and mature breast milk both run around 20 calories per fluid ounce. Premature infants often cannot tolerate the volume required to grow at that concentration, so hospitals use products at 24 or 30 calories per ounce to deliver more nutrition in less fluid.

That is what Special Care 24 and Premature 24 Cal mean. A 22 calorie product such as NeoSure or EnfaCare sits between the hospital concentrations and standard formula, which is why it is used in the weeks after discharge. The numbers do not indicate a product generation, and a record showing more than one concentration usually means the feeding plan was adjusted, not that a different product line was substituted.

Hospital Products Versus the Cans in the Store

The preterm formulas and fortifiers above are supplied to hospitals and are generally not sold to the public. They arrive in small ready-to-feed bottles or vials, are ordered by the neonatology team, and are prepared by hospital staff. A family may never see the packaging at any point.

The retail products most people picture, including Enfamil NeuroPro Infant, Similac 360 Total Care, Similac Advance, and the sensitive and gentle varieties, are ordinary term infant formulas. They are not the hospital preterm products these lawsuits concern. The post-discharge transitional formulas, EnfaCare and NeoSure, sit in between, since a family may have bought those at a store after leaving the NICU.

The 2022 Abbott Recall Is a Different Issue

In February 2022 Abbott recalled certain powdered formulas, including some Similac, Alimentum, and EleCare products, made at a plant in Sturgis, Michigan, after reports of bacterial infections in infants. That recall concerned contamination of specific lots and led to a national formula shortage.

The NEC litigation is a different matter. It does not allege that the products were contaminated. It alleges that cow's-milk-based preterm formulas and fortifiers carry a risk of NEC in premature infants and that the manufacturers did not adequately warn about it. A product involved in the 2022 recall is not part of this litigation on that basis alone, and a product never recalled can still be named in a NEC case.

Where the Product Name Appears in Medical Records

The hospital record is normally the only place the specific product is written down. The entries that tend to carry it are:

• NICU feeding and nutrition orders, which name the product and the concentration
• Daily intake and output flow sheets, which show volumes and timing
• Nursing notes and the dietitian's or lactation consultant's notes
• The discharge summary, which often recaps the feeding course
• The itemized hospital bill, which sometimes lists nutrition products by name

Records are requested from the hospital's medical records or health information management department, usually with a signed authorization form. For a living child, a parent or legal guardian ordinarily makes the request. Where an infant died, the person entitled to request the record is generally the personal representative of the estate or the next of kin, and which one applies depends on state law. Hospitals keep pediatric records for a period set by state retention rules, and those periods are long but not unlimited.

Why Product Identification Matters

These claims are product-specific and manufacturer-specific. A case involving Enfamil products is brought against Mead Johnson, and a case involving Similac products is brought against Abbott. Many NICU infants receive products from both companies over the course of a stay, sometimes in the same week, which is one reason the feeding record does more work here than memory can.

The same records answer the surrounding questions. They show when feeding started and what the infant received before the NEC diagnosis, whether mother's milk or pasteurized donor milk was used, whether the hospital had a donor milk program at the time, and what the treating physicians documented. Those details describe the infant's actual course of care, and they are the reason two families with similar-sounding stories can be in very different positions.