Update: Abbott Recalls Enfamil Baby Formula After Reports of Illnesses, Including Infant Death
The U.S. Food and Drug Administration is warning consumers to avoid certain powdered infant cow milk formulas that may be tied to bacterial infections in four babies who were hospitalized .
The infections, which may have led to the death of one baby, were found in Texas, Ohio, and Minnesota, FDA said.
The agency is advising that people should avoid using Similac baby formula, Alimentum, or EleCare powdered infant formulas if the first two digits of the code are 22 through 37; the code on the container contains K8, SH, or Z2; the expiration date is April 1, 2022, or later.
Three infections stemmed from Cronobacter, a bacteria that can cause severe, life-threatening infections or inflammation of the membranes that protect the brain and spine. The third infection was from Salmonella, a group of bacteria that can cause digestive illness and fever.
“Parents and caregivers of premature infants who have used these products, and are concerned about the health of their child, should contact their child’s health care provider,” the FDA said in the news release.
What's the Problem with Enfamil?
A premature baby does best on natural milk for a balanced diet. However, breastfeeding is not always possible in NICUs.
Many premature babies also need additional calories, so many NICU medical professionals use natural milk with an Enfamil human milk-based fortifier.
Unfortunately, most infant formula products are cow's milk-based, which is difficult for premature infants to digest properly, leading to a severe and often deadly gastrointestinal disease known as necrotizing enterocolitis NEC.
Related Article: Baby Formula NEC Lawsuit
Studies Link Enfamil to Increased Risk of NEC
Numerous studies have found that human milk fortifier-based infant formula products can increase the risk of preemies developing NEC. The risk of sepsis increased in preemies by nearly 18% for every 10% increase in the formula, the studies found.
What is Enfamil?
Enfamil is a 20 Cal/fl iron-fortified, human milk fortifier formula for low birth weight infants 0-12 months, according to information presented on the company's website. Enfamil Infant is intended to foster cognitive development through 5 years of age.
Enfamil is patterned after mature breast milk and is designed to enhance future results of brain development, immune health, and growth.
What Ingredients Does Enfamil Contain?
Enfamil contains the following ingredients:
- Nonfat milk
- Human milk fortifier
- Vegetable oil (palm olein, coconut, soy, and high oleic sunflower oils)
- Whey protein concentrate and less than 2% Galactooligosaccharides
- Mortierella alpina oil
- Crypthecodinium cohnii oil
- Calcium carbonate
- Potassium Citrate
- Ferrous sulfate
- Potassium chloride
- Magnesium oxide
- Sodium chloride
- Zinc sulfate
- Cupric sulfate
- Manganese sulfate
- Potassium iodide
- Sodium selenite
- Soy lecithin
- Choline chloride
- Ascorbic acid
- Calcium pantothenate
- Vitamin A palmitate
- Vitamin B12
- Vitamin D3
- Thiamin hydrochloride
- Vitamin B6 hydrochloride
- Folic acid
- Vitamin K1
- Vitamin E acetate,
- Nucleotides (cytidine 5’-monophosphate, disodium uridine 5’-monophosphate, adenosine 5’-monophosphate, disodium guanosine 5’-monophosphate)
How to Prepare Enfamil
Parents should either feed Enfamil Baby Formula or similar human milk fortifier to infants immediately or cover and store in the refrigerator at 35–40°F (2–4°C) promptly for no longer than 24 hours. Parents should not use prepared human milk fortifier if it is unrefrigerated for more than a total of 2 hours. Do not freeze the prepared formula. After feeding begins, parents should use a human milk fortifier within 1 hour or discard it.
Is Enfamil FDA Approved?
No. The U.S. Food and Drug Administration does not approve human milk fortifier products before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and toxic baby formula manufacturers must notify the FDA before marketing a new formula.
Which Formulas Use Cow's Milk as Base?
About 80% of infant formulas are cow’s milk-based, and almost every major brand (and store brand equivalent) offers consumers and parents a bovine-based product, including:
- Similac Special Care
- Human Milk-Based Fortifier
- Earth’s Best
- Happy Baby
- Go & Grow
- Parent’s Choice
- Baby’s Only
What is Necrotizing Enterocolitis NEC?
NEC is a serious gastrointestinal problem that mostly affects premature infants. The condition inflames intestinal tissue, causing it to die if not treated promptly.
A hole (perforation) may form in the intestines of a child with NEC. Dangerous bacteria can leak into the abdomen or bloodstream through the hole. Children develop NEC within 2 to 6 weeks after birth.
In some infants, NEC is mild. Others experience severe, life-threatening symptoms.
- High fever
- Excessive sleepiness
- A swollen, red, or tender belly
- Baby's head stiffness
- Neck seizures
- Abdominal Distension
- Brain and spinal cord injury
- Feeding Intolerance
- Cronobacter infection
- Hypotension (low blood pressure)
- Bradycardia (slow heart rate)
- Temperature Instability
- Blood tests: Doctors may order a blood test, which checks for dangerous bacterium and other signs of bacterial infection.
- Fecal test: This test checks for blood in your infant's feces.
- X-rays: Abdominal X-rays can show signs of NEC, including air bubbles (gas) around the intestine or abdominal cavity of the child.
Necrotizing enterocolitis NEC may require medication, but severe cases will require surgery – and even the surgery may pose serious risks of permanent injury to premature babies.
In some cases, scarring and narrowing of the bowel may develop and can lead to future intestinal obstruction or blockage.
If you are at risk for preterm birth, you may get corticosteroid injections. This medication boosts an unborn baby’s health. It may lower your baby’s chances of lung and intestinal problems.
The prognosis (Outlook)
An estimated 8 in 10 babies with NEC survive. Some of these children will have long-term health problems from NEC.
Complications of NEC may include:
- Abdominal infection
- Intestinal stricture
- Short bowel (short gut) syndrome
- Growth failure / developmental delays
Who is at Greatest Risk?
Nearly all babies — 9 out of 10 — who get NEC are born early. The condition mostly affects babies:
- Born before the 37th week of pregnancy (premature baby)
- Fed through a tube in the stomach (enteral nutrition)
- Weighing less than 5 1/2 pounds at birth
How Common is NEC?
In premature infants, NEC is a common serious illness. It affects 1 in 1,000 premature babies. The risk is greatest for children weighing less than 2 pounds.
What are the Types of Necrotizing Enterocolitis?
Healthcare providers classify NEC into types based on when symptoms start and what causes the condition. The different types of NEC include:
This most common type of NEC tends to affect infants born before 28 weeks of pregnancy. Classic NEC occurs three to six weeks after birth. In most instances, the infant is stable and doing well. Then the condition comes on suddenly, without warning.
An infant may need a blood transfusion to treat anemia (lack of red blood cells). About 1 in 3 premature babies develop NEC within three days of getting a blood transfusion.
Rarely, a child develops NEC in the first week of life or before the first feeding.
Term infant NEC
Full-term babies who get NEC usually have a birth defect. Possible causes include congenital heart condition, gastroschisis (intestines that form outside of the body), and low oxygen levels at birth.
Other Enfamil Side Effects
In addition to an increased risk for necrotizing enterocolitis, baby formulas have been linked to more moderate side effects including constipation, diarrhea, and upset stomach. These effects are usually temporary and may disappear as the baby's body adjusts to the medication.
Human Breast Milk vs. Formulas: How Similar Are They?
There are ways in which formulas are similar to breast milk: they both provide energy, healthy foods, hydration, and nutrients, so your infant will grow whichever milk he is given.
However, despite advances in how baby milk powder is formulated and manufactured, it doesn’t come close to matching the health benefits of human breast milk.
Why Breast Milk is Better for Babies
Human milk has evolved over millions of years to be the perfect health food for human babies. It’s much more complex than cow's milk, as it builds our more complex brains and unique digestive and immune systems.
In contrast, cow’s milk, from which most formulas are made, meets the specific needs to be fed to calves. It’s not safe for human babies to drink, so has to be processed intensively when made into formulas to be fed to infants.
Heavy Metals Found in Enfamil Baby Formula, Cereals
A report issued by the U.S. House of Representatives in February 2021 has found that virtually all infant foods contain dangerously high levels of at least 4 toxic metals.
Infant foods, purees, cereal, teething snacks, juices, and formula were all tested and found to contain lead, arsenic, cadmium, and mercury.
These toxins can lower IQ levels and are especially harmful to infants’ developing brains.
Related Article: Baby Food Toxic Metals Litigation & Attorneys
Whistleblower Suit Alleges Enfamil Powdered Infant Formulas Defectively Packaged
Enfamil containers that were allegedly vulnerable to spoilage are at the center of a whistleblower claim filed by a former compliance director for Mead Johnson who claims she was eventually fired after raising concerns about packaging defects.
Plaintiff Linda O'Risky, who was a consultant and employee for Mead Johnson for over 25 years, claims in a recent NEC lawsuit filed in U.S. District Court in Chicago that the company "touted its hermetically sealed liquid formulas as safer than powder formulas," but in reality, the seals were prone to leaking, making it easier for microorganisms and other contaminants to enter the packaging.
CVS Pulls Enfamil Off Shelves Nationwide
CVS in August 2018 pulled all powdered infant formula products off its shelves after customers complained that some of the packages had open seals.
"The bag was in it like this, this particular sticker was not fully attached and when I opened it up this seal that wraps around was opened,” said one mother who purchased Enfamil from CVS. "This smells like typical baking flour,” she said pointing to the container she said was tampered with.
This has been reported in states across the U.S. - a woman was even arrested in Tucson, Arizona, after she was found guilty of swapping baby formula with flour at stores in that area, including 2 Walmarts.
Mead Johnson Accused of Selling Baby Formula Containing Bugs
A New York City woman in March 2017 filed an Enfamil baby formula lawsuit accusing Mead Johnson of selling baby formula that was contaminated by dead insects, claiming that her infant daughter had to be hospitalized twice after consuming the company’s Enfamil baby formula.
In an NEC baby formula lawsuit entered in the U.S. District Court for the Eastern District of New York, Brooklyn resident Paulina Rodriguez alleges that she was misled into purchasing an unsafe product because of Mead Johnson’s negligent manufacturing processes.
Rodriguez said she found insects in the company’s formula on four occasions, starting in November 2016.
What are NEC Baby Formula Lawsuits Alleging?
If your baby received Enfamil in a hospital or NICU, or if they developed necrotizing enterocolitis after taking Enfamil, you can file a baby formula lawsuit against the manufacturers with the help of our attorneys.
These baby formula lawsuits allege that Mead Johnson knew about the risk of developing NEC, but failed to warn parents of this risk.
If your child suffered harm from NEC after being fed Enfamil formula, he or she may require a lifetime of care and medical help to deal with complications of the disease. Tragically, you may even have experienced death from this condition. When this occurs, you need someone on your side who can fight for justice.
Enfamil Lawsuit Settlement Information
The lawsuits filed against the makers of Enfamil baby formula have been consolidated into a multidistrict litigation, or MDL, which is likely to result in one or more “bellwether" trials. The result of the bellwether trials will help gauge whether juries are likely to rule in favor of the defendant or the plaintiffs and whether an Enfamil settlement or other resolution will be reached before other similar individual lawsuits reach the trial phase.
If the bellwether trials fail to conclude in settlement agreements or verdicts in favor of the plaintiffs, then the presiding judge may send the cases back to their original jurisdiction to be tried as individual cases.
Another important criterion that the bellwether trials will measure is how much compensation juries are likely to award to plaintiffs who do win Enfamil Baby Formula Lawsuits. Said compensation does not guarantee future outcomes but may provide a reasonable estimate for potential settlement amounts moving forward.
See other food poisoning lawsuits we're currently taking.
Get a Free Enfamil Baby Formula NEC Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Enfamil Baby Formula Lawsuits. We are handling individual litigation nationwide and currently accepting new toxic baby formula lawsuits in all 50 states.
If your baby or other loved one received Enfamil formula in a hospital / neonatal intensive care unit (NICU), or if your premature baby developed necrotizing enterocolitis, you should contact our law firm immediately for a free case evaluation. You may be entitled to a settlement by filing a baby formula and we can help.