Similac Formula Lawsuit & Recall - Necrotizing Enterocolitis (NEC)

It’s estimated that around one in ten babies are born preterm (before 37 weeks of pregnancy) in the United States each year. That equates to around 400,000 “preemies” born each year, many of whom are underweight and likely to experience difficulty in feeding, particularly breastfeeding. Brands like Similac, which is marketed by Abbott Laboratories as the #1 premature infant formula brand, are supposed to offer a lifeline to parents of preterm babies, helping their little ones gain weight as well as the vital nutrition needed to develop in those early weeks and months. However, studies have uncovered a worrying link between cows-based formula like Similac and NEC (necrotizing enterocolitis), a potentially life-threatening disease that attacks the infant’s intestines. As evidence mounts against Abbott Laboratories, many Similac preterm formula lawsuits have been launched to secure justice for parents of infants affected by NEC. 

Several important studies have concluded that there is a link between formula based on bovine (cow’s) milk and NEC. Around 90% of NEC cases are found in preterm babies. And while that doesn’t unequivocally prove that Similac causes NEC, experts are certain that preterm babies fed cow’s milk-based formula are more likely to develop NEC than those fed on breastmilk. The studies linking formulas like Similac to NEC go back to the 1990s, and new studies on formula and NEC are uncovering more evidence on the risks. The NEC lawsuit aim to uncover what exactly Abbott knew about the link between Similac and necrotizing enterocolitis and why the company continued to aggressively market its products towards parents of preterm babies. 

April 1, 2025

Longitudinal fecal microbiota and volatile metabolomics preceding necrotizing enterocolitis in preterm infants.

February 1, 2025

Digging deeper into Necrotizing Enterocolitis: bridging clinical, microbial, and molecular perspectives.

• January 1, 2025 - NEC Treatment & Management
• December 1, 2024 - Hundreds of lawsuits allege Abbott Laboratories' formula for premature infants made babies sick. But is the formula to blame?
• November 1, 2024 - Closings Start Wednesday In Bellwether NEC Baby Formula Trial.
• August 1, 2024 - Nutrition companies, parents clash in court over cause of infant intestinal disease. The companies say no published study's ever concluded their products cause NEC.
• July 1, 2024 - FDA Warning on Probiotics for Prevention of NEC Causes Shift in Care
• June 1, 2024 - U.S. District Judge Matthew Kennelly tosses out some claims in Abbott baby formula litigation.
• May 1, 2024 - Minnesota mom claims baby formulas have a hidden risk. Hundreds of parents are suing, claiming formula makers failed to warn that premature infants fed cow's milk formulas were at higher risk for Necrotizing Enterocolitis, a devastating illness.
• March 1, 2024 - Why nationwide lawsuit alleging formula causes deadly disease in preemies is heading to Illinois.
• February 1, 2024 - Detecting NEC quickly saves premature babies.
• January 1, 2024 - Cronobacter, the bacteria that caused formula recalls, has now killed a baby and damaged another's brain.
• December 1, 2023 - Similac probiotics product under recall after adverse reactions in preterm babies.
• November 1, 2023 - FDA issues warnings about preterm infants probiotics.
• October 1, 2023 - Parents say the baby formula shortage is still not over. One year after the Abbott baby formula recall, parents say it's still hard to find certain types of baby formula.
• July 25, 2023 - UPMC Children's Hospital study looks to save pre-term babies through antibodies in breast milk.
• July 1, 2023 - After reports of a second infant's death, the baby formula recall includes Similac PM. The FDA is investigating complaints from consumers and/or reports about infant illnesses related to products manufactured by Abbott Nutrition in Sturgis, MI. (FDA)
• June 1, 2023 - Why do baby formula recalls continue to occur?
• May 1, 2023 - FDA waited months before recalling Similac baby formula.
• April 1, 2023 - Ex-FDA Official: The US is at Risk of another baby formula shortage without fixings House hearing to examine FDA's response in the USA to US shortage.
• March 1, 2023 - Abbott initiated a voluntary, proactive recall of powder formulas including Similac and Alimentum, which were manufactured at one of the company’s facilities in Sturgis. The recall does NOT include any nutritional formulas for metabolic deficiencies.
• February 1, 2023 - Parents can check if a baby formula is included in the recall online by entering your lot number on Abbott's recall site.
• January 1, 2023 - FDA Report Faults Agency’s Food Unit for Leaderless Dysfunction
• December 1, 2022 - Enforcement Discretion to Manufacturers to Increase Similac Infant Formula Supplies.
• November 16, 2022 - Abbott recalls Similac baby formula in the U.S. (Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort & Similac NeoSure).
• October 1, 2022 - AR parents sue Abbott after their baby sickened by powdered formula.
• September 1, 2022 - Procedures at the Similac factory in Sturgis, Michigan became careless, and cronobacter bacteria spread. When the FDA finally did something about it, it found itself overwhelmed.
• August 14, 2022 - Baby formula shortage persists. Similac Advanced & Similac Sensitive are coming back into the market.
• August 1, 2022 - Brianna Anthony, Charlotte mom claims in lawsuit that Similac led to premature baby's death.
• July 1, 2022 - The death of another baby linked to Abbott baby formula apparently under investigation.
• June 1, 2022 - In May 2022 we have received about 56 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac formula (48%) listed on this page and other formulas Enfamil(39%), the other 13% were Gerber, Earths Best or another cows milk-based formula.
• May 1, 2022 - In April 2022 we have received about 57 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac formula (38%) listed on this page and other formulas Enfamil(33%), the other 29% were Gerber, Earths Best or another cows milk-based formula.
• April 1, 2022 - In March 2022 we have received about 90 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac formula (39%) listed on this page and other formulas Enfamil(31%), the other 30% were Gerber, Earths Best or another cows milk-based formula.
• March 1, 2022 - Last month we have received over 240 inquiries on our site from parents of babies with NEC who fed their babies problematic Similac formula (40%) listed on this page and other formulas Enfamil (30%), the other 30% were Gerber, Earths Best or another cows milk-based formula.
• February 20, 2022 - Parents, if you are concerned about the formula, here are some things you can look out for:
  • The code on the container contains K8, SH or Z2
  • The first two digits of the code are 22 through 37
  • The expiration date is April 1, 2022 or later
• February 18, 2022 - The FDA advises against using these baby formulas after four infants have been admitted to the hospital. Abbott Nutrition, maker of the Similac and Alimentum brands, issued a voluntary recall on Thursday for certain formulas made at its Sturgis plant, Mich., where they were involved in the infection.
• February 1, 2022 - U.S. National Library of Medicine - Testing of A Mouse Model of NEC - Induction of NEC in Neonatal Mice.

The Similac lawsuits are still at an early stage, with specialized child injury law firms asking that parents affected by Similac NEC come forward to begin an NEC compensation claim. Many lawsuits have been filed against Abbott Laboratories, as well as Mead Johnson. Some of the NEC lawsuits allege wrongful death, whereas others focus on injuries allegedly caused by Similac products. Around one in ten babies with low birth weight (common among preterms) get NEC, so it is possible that there are many thousands of families who can join the Similac lawsuits in 2022.

There are many reported side effects of Similac usage, not all of which are linked to NEC cases. Similac baby formula side effects can include:

• Nausea, vomiting, stomach cramps
• Coughing, wheezing, breathing problems
• Constipation, diarrhea, black stool
• Hives and rashes
• Low blood pressure

It’s important to point out that these symptoms are not necessarily evidence of NEC, although some signs of NEC do include symptoms like nausea and vomiting. Regardless, if your baby is experiencing Similac side effects, you should contact your doctor immediately. In addition, it’s important to keep in mind that symptoms of NEC might not be apparent soon after ingesting Similac, and the NEC may only be discovered after the doctor has performed an X-ray or other investigations.

To be clear, Abbott makes a lot of products under the Similac brand, and not all are linked to causing NEC or covered in the Similac lawsuits. The focus is on certain cow’s milk-based formula products, including Similac NeoSure, Similac Special Care, and Similac Human Milk Fortifier, specifically made for babies born preterm or with related issues like low birth weight. Moreover, Abbott is not alone in producing products focused on treating these young babies. For instance, Enfamil, which is produced and marketed by Mead Johnson and Company, is also part of the ongoing preterm formula lawsuits. Cases have been filed against both these two large, multinationals: Mead Johnson and Abbott Laboratories. Indeed, it is possible that parents taking legal action for NEC will have used products from both companies. If your child suffered from NEC after using either Enfamil or Similac products, you are being urged to contact an NEC formula lawyer to begin your claim for compensation.

As of 2022, there has been no recall of Similac preterm baby formula products by the FDA, nor on a voluntary basis by Abbott Laboratories. There have been Similac recalls in the past, including a 2010 recall after beetle larvae was found in products made in a plant in Michigan. It is possible that there will be a 2022 Similac recall depending on the evidence found in the NEC lawsuits and other studies that link Similac and this disease.

Similac products linked to NEC include:

• Similac Alimentum
• Similac Alimentum Expert Care
• Similac Human Milk Fortifer Hydrolyzed Protein Concentrated Liquid
• Similac Human Milk Fortifier
• Similac Human Milk Fortifier Concentrated Liquid
• Similac Human Milk Fortifier Powder
• Similac Liquid Protein Fortifier
• Similac Special Care 20
• Similac Special Care 24
• Similac Special Care 24 High Protein
• Similac Special Care 30

Lawyers in the Similac formula lawsuits are aiming to secure suitable compensation for parents of children affected by NEC. A Similac lawsuit payout may occur after being settled out of court, or at the conclusion of a trial against Abbott Laboratories. At this stage, estimating the amount you could get for a Similac NEC settlement is difficult, as it will depend on factors like level of injury, the proven culpability of Abbott Laboratories, and so on. However, we do know that these companies should be held accountable to the full extent of the law. And if it is proven that Abbott knowingly marketed these products and caused, in some cases, the death of a child, the Similac NEC settlements could be huge, potentially reaching millions of dollars.

As mentioned earlier, Similac lawsuits are at an early stage. Some cases have gone to court for preliminary hearings, but we are still at the stage where Similac formula lawyers are gathering evidence and calling for more parents to come forward to begin their claim. However, due to the potentially large number of claimants across the United States, it is likely that the Similac cases will be consolidated into an MDL (multidistrict litigation). An MDL is a type of mass tort lawsuit used to streamline complex civil cases for reasons of efficiency in the courts. In essence, an MDL will combine all (or most of) the Similac lawsuits together, allowing for sharing of resources (evidence) and greater efficiency. It is important to point out that there is a difference between an MDL/mass tort and a class action. The latter treats the consolidated cases as a single issue, paying claimants equal compensation. While an MDL combines the cases, each claimant is treated separately. This is important when it comes to gauging the amount of compensation paid, as each is judged on a case-by-case basis.

Does Abbott make Similac?
Yes. Similac baby formula products are produced and manufactured by Abbott Laboratories. The brand has been around for almost 100 years, and it is one of the best-selling brands of baby formula products in the United States and around the world.

Is Similac bad for your baby?

The risks of Similac are part of the lawsuits against Abbott Laboratories. However, they focus on Similac risks primarily in preterm and low birthweight babies. Similac is a brand name covering many different products, not all of which are under scrutiny for being harmful. If you are worried about giving your baby Similac, contact your child’s pediatrician or other healthcare professional.

Is Similac FDA approved?

The FDA does not approve baby formulas. This is due to the fact baby formulas are considered food. However, manufacturers of baby formulas must meet certain nutritional requirements to satisfy the FDA before they can be launched on the market.

Is Similac formula toxic?

We simply do not know the harmful effects of Similac, and we hope more evidence comes to light during the Similac lawsuits. However, we do know for certain that there is a link between cow’s milk formula like Similac and the potentially very harmful disease NEC.

Is Similac made in the USA?

Yes. While Similac is sold around the world, Similac sold in the United States is made here. Some parents have been asking if Similac is made in China. The answer is no, as Chinese-produced baby formulas are banned for sale in the United States.

Is there a Similac Recall?

Not yet. There have not been any recalls of Similac products by the FDA due to the NEC link. In the past, Abbott Laboratories has recalled Similac, but these recalls were due to particular and limited contaminations in the manufacturing process.

What are the side effects of Similac?

There are several reported Similac side effects, which include vomiting, stomach pain, constipation, coughing, and diarrhea in infants. The basis of the Similac lawsuits is that there is a link between the formula and the disease, necrotizing enterocolitis. If your baby is showing side effects following ingesting formula like Similac, you should contact your doctor immediately.