Baby Formula NEC Lawsuit
Parents of premature infants diagnosed with necrotizing enterocolitis (NEC) after using certain baby formulas may be eligible to file a lawsuit. Several Similac and Enfamil formulas are cited in NEC lawsuits. In July 2024, a St. Louis jury awarded $495 million to the family of an infant who developed NEC after being fed Similac. If you have been impacted, Drugwatch can connect you with a baby formula lawyer to see if you qualify for a lawsuit to seek financial compensation.
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- Legally reviewed by Brendan A. Smith, Esquire
- Last update: November 10, 2025
- Est. Read Time: 10 min read
- Who May Qualify:
- Parents or guardians of premature infants who developed NEC after they consumed cow’s milk baby formulas, most commonly Similac and Enfamil, manufactured by Abbott Laboratories and Mead Johnson.
- Evidence to Gather:
- Imaging tests, baby formula purchase receipts, NICU feeding orders, medical records that show evidence of NEC, and an official diagnosis and treatment plan.
- MDL 3026:
- There are 755 cases pending as of November 2025 in the U.S. District Court, Northern District of Illinois (Master docket number: 1:22-cv-00071).
- Recent Verdicts:
- In March 2024, $60 million was awarded in Illinois state court, and in July 2024, $495 million was awarded in Missouri state court.
Why Are People Filing Baby Formula Lawsuits?
NEC baby formula lawsuits allege that manufacturers failed to adequately warn parents and healthcare providers about the heightened risk of necrotizing enterocolitis (NEC) in premature infants fed cow’s milk formulas. Scientific evidence suggests these products may be especially dangerous for this vulnerable population.
We’ve heard from parents and grandparents who have told us their tragic stories about an infant who suffered from NEC. The experiences they have been through are heartbreaking. In many cases, parents have told us they filed a lawsuit to hold baby formula makers accountable for negligent behavior.
NEC baby formula lawsuits state that Abbott and Mead Johnson should have warned about the risk of NEC linked to Similac and Enfamil but continued to market these products as safe. NEC is rare, but it is serious and can be deadly for low birth weight and preterm infants.
Marie Smith filed her lawsuit against Mead Johnson and Abbott Laboratories after her premature infant, Amirea, died from NEC after just two weeks of life. Smith keeps her daughter’s baby blanket and clothes to remember her. While a jury verdict won’t bring her daughter back, she hopes to spread awareness and spare another family the same fate.
“This is a feeling I would not wish on anyone… I feel like people have been lied to,” she told NBC affiliate KARE 11.
The Dangers of NEC
Necrotizing enterocolitis (NEC) is a life-threatening gastrointestinal disease in premature infants that often requires surgery and carries a high risk of mortality — up to 50% in severe or surgical cases. Many survivors face lasting complications such as neurological impairment, nutritional deficiencies and growth problems.
Sometimes, babies must undergo surgery to remove parts of their intestinal tract, leading to other lifelong issues. Even after surgery, mortality rates may be as high as 57%.
- No Warnings
- • No warnings about the risk of NEC or death
- • Defendants knew or should have known their products were not safe for preemies
- • Defendants designed misleading marketing to convince doctors and parents of safety
- NEC and Preterm Infants
- • Advanced cases of NEC may lead to surgery and even death
- • NEC is more common in preterm infants fed cow’s milk formula versus breast milk
- • Alternatives to cow’s milk fortifiers and formulas exist
- NEC Studies
- • 1990: NEC is six to 10 times more common in exclusively formula-fed preemies
- • 2009: Preemies on human milk-based 90% less likely to develop surgical NEC
- • 2014: Up to 30% of preterm infants will die from NEC
“This is a feeling I would not wish on anyone… I feel like people have been lied to.”
Who Qualifies to File an NEC Baby Formula Lawsuit?
Parents and legal guardians who had a premature or low birth weight infant that was fed cow’s milk baby formulas and then diagnosed with NEC may qualify to file an NEC lawsuit. Law firms also have specific qualifications a claimant must meet.
- The child must be a preterm or low birth weight infant.
- Medical diagnosis of NEC documented in NICU medical records.
- Documented exposure to Similac/Enfamil preterm NICU products or cow’s milk-based fortifiers. These can be found in hospital feeding orders.
- NEC diagnosis that occurs with hospital/NICU formula feeding or formula feeding after hospital discharge.
- Documented hospitalization or medical intervention for NEC complications.
In some cases, you may file a lawsuit years after your child was diagnosed with NEC. There are time limits called statutes of limitations (SOL), however. SOLs can range from one to six years, depending on your state. The time limit may be subject to a discovery rule, which also varies by state, and may give you more time to file. The discovery rule says the statute of limitations doesn’t begin to run until the date you discovered your child’s injury.
Only an attorney can tell you the time limit for you, so we recommend you contact a lawyer right away to preserve your right to file a claim.
Award-winning baby formula lawyer Brendan Smith answers important questions about baby formula lawsuits.
- What’s the most important thing people should know about NEC lawsuits?
The intricacies of NEC baby formula lawsuits, which encompass detailed scientific and legal elements, necessitate potential plaintiffs finding a law firm with a proven track record in handling complex litigations against major corporations. It's essential to have your case thoroughly reviewed and your rights safeguarded.
- What are the qualifications for filing a lawsuit?
If your loved one consumed NEC baby formula, suffered an injury, and was diagnosed with necrotizing enterocolitis (NEC), you might qualify to file an NEC lawsuit and seek financial compensation.
- What should people expect after contacting a firm to file a suit?
A team comprising lawyers, paralegals, and legal assistants will consult with you, collect case details, and obtain and review medical records. When the time is right, your lawyers will file the lawsuit and coordinate with you if further information is required.
Baby Formula Lawsuit Evidence Checklist
A checklist of evidence to gather for your case can help you speak to an attorney and strengthen your case. A strong NEC baby formula lawsuit relies on gathering comprehensive documentation that shows your child’s diagnosis, formula exposure, medical impact and damages.
- Abdominal imaging reports (X-rays, CT scans, etc.)
- Baby formula packaging labels you may have saved
- Expert opinions on your child’s diagnosis and treatment
- Feeding schedules and logs
- Hospital discharge summaries and follow-up notes
- Hospital name and location
- Medication Administration Records (MARs)/baby formula information entries (brand, fortifier and lot if available)
- NICU feeding orders and attending notes
- Operative and pathology reports for NEC treatment
- Proof of baby formula purchase (receipts or bank statements)
- Records detailing any damages, such as medical bills, lost wages, pain and suffering and out-of-pocket expenses
Baby Formula Lawsuit Settlement Compensation
There hasn’t been a global settlement announced yet. Law firms representing families in the baby formula NEC litigation estimate that individual payouts could range from $50,000 to $600,000. So far, verdicts paid out to plaintiffs have totaled $555 million.
The settlement figures are speculative, and estimates could change as the litigation evolves. Many factors can affect payouts.
The outcome of the upcoming bellwether trials in the federal MDL could play a big role in determining eventual settlement amounts. If plaintiffs were to see success in these test trials, then Abbott and Mead Johnson could be motivated to negotiate a settlement instead of continuing to try individual cases.
Plaintiffs have had big success in state court. In July 2024, a St. Louis jury awarded $495 million to the family of an infant who developed NEC and was left with permanent, life-altering conditions.
This was just months after an Illinois jury awarded $60 million to a mother in a similar case.
Abbott and Mead Johnson’s only win in the litigation, which went to trial in October 2024, was later wiped out by a judge.
Factors That Affect the Value of an NEC Baby Formula Settlement
The value of an NEC baby formula lawsuit settlement depends on several key factors that impact both the calculation of damages and the likelihood of a favorable outcome for the plaintiff.
Each case is different. Make sure to discuss your unique case with your lawyer.
- Amount of medical expenses incurred and anticipated for future care (such as surgeries, hospitalization and rehabilitation).
- Any lost wages or future lost earning potential due to disability.
- Degree of permanent disability, developmental delay or need for lifelong medical attention.
- Level of proven negligence or failure to warn by the formula manufacturer — cases with strong evidence of corporate wrongdoing may result in higher (punitive) awards.
- Pain, suffering and emotional distress experienced by the child and family.
- Severity of the child’s NEC diagnosis (including whether there was death, permanent injury or full recovery).
- Strength and clarity of evidence linking the formula to NEC in the child.
- Venue (state vs. federal court) and the makeup of the jury or judge who will decide the case.
- Whether the case involves wrongful death, which may include higher compensation for funeral costs and loss of companionship.
Each of these factors can shift the value of an NEC baby formula lawsuit. Cases with severe outcomes, strong evidence and seriously negligent conduct by manufacturers tend to settle for higher amounts.
Finding an NEC Baby Formula Lawyer
The easiest way to find a baby formula lawyer is to click on our free case evaluation link on this page. You’ll be connected with our legal partners who are award-winning lawyers with extensive experience in complex litigation like baby formula lawsuits. They have been fighting against negligent corporations for many years on behalf of their clients and have track records of recovering billions of dollars in compensation.
Deciding who will represent you is an important decision. We recommend finding an NEC baby formula lawyer who has experience handling mass torts, which are large litigations for hundreds or thousands of claimants. These torts are typically against large corporations with big legal teams of their own, such as Mead Johnson and Abbott in this litigation.
Baby formula lawsuits are complex and could involve a lot of complicated science and law. Lawyers with extensive experience in large injury litigations are equipped to gather the proper evidence and prove their client’s case before a judge or jury. It’s also helpful to find an NEC baby formula lawyer who works with a firm that has a track record of settling cases and getting jury verdicts.
Cassidy (using an alias to protect privacy) sought help from Drugwatch after she found out cow’s milk baby formula could be responsible for the NEC complications her teenage daughter Addison (using an alias) has lived with all her life. Addison lives with serious digestive issues where the acid reflux from her stomach makes her esophagus swell, making it hard to swallow. She has to take injectable medication to make sure her throat doesn’t close.
“I have GERD, so it’s like it goes all up in my throat and it makes it swell. And so it’ll close up, and I can’t eat and drink. Yeah, I throw up my food a lot,” Addison said.
Drugwatch matched Cassidy and Addison with an experienced lawyer who will help them file a lawsuit and seek compensation.
What Experts and Patients Say About Baby Formula and NEC
Latest NEC Baby Formula Lawsuit Updates
As of November 2025, there were 755 necrotizing enterocolitis baby formula lawsuits pending in multidistrict litigation. MDL 3026 is before U.S. District Judge Rebecca Pallmeyer in the Northern District of Illinois.
There have been no approved settlements or jury verdicts in the Illinois MDL, which contains mostly Similac and Enfamil lawsuits, but a state court case in Illinois ended in a $60 million plaintiff’s verdict in March 2024. Another state court case in Missouri ended in a $495 million plaintiff’s verdict in July 2024. In October 2024, a St. Louis jury sided with both Abbott and Mead Johnson in the latest baby formula trial, breaking the trend of previous cases.
A federal judge has awarded summary judgment to Abbott in three straight bellwether trials. Work on a second wave of bellwether cases is now underway.
Through our research of court documents and discussing these lawsuits with our legal partners, we’ll continue to provide updates and inform you of key moments in this litigation.
Baby Formula Litigation Timeline
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November 10, 2025: Why the Next Baby Formula Bellwether Trial Will Be Different
Abbott has now secured summary judgment victories in three baby formula bellwether cases. As preparations begin for a second wave of bellwether trials expected in late 2026, one case from the initial group remains unresolved. Unlike the others, this remaining case is the first federal bellwether involving Mead Johnson’s Enfamil formula. The case will serve as a significant test for plaintiffs alleging that Enfamil can cause NEC in premature infants. Should the case make it past summary judgment, the trial is likely to begin early next year.
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November 3, 2025: Small Dip in Number of Active Baby Formula Lawsuits
At the start of November, 755 baby formula lawsuits are active in federal court. This is a modest drop of six cases from this time a month ago. The path forward for these cases in federal court remains a bit rocky after Abbott won the first three bellwether trials on summary judgment, but more cases have been scheduled to go to trial in 2026 and 2027.
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October 28, 2025: Second Wave of Bellwether Trials to Begin in August 2026
With yet another bellwether trial failing to make it to a jury, the baby formula MDL is moving quickly to get a second wave of bellwethers up and running. The first of those cases has been slated to go to trial in August 2026, with two more following in November 2026 and February 2027. Pretrial work has already begun.
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October 27, 2025: Third Straight Bellwether Trial Defeated
Judge Pallmeyer has once again granted a victory to Abbott, awarding summary judgment to the formula maker in the third straight bellwether trial. This is an unfortunate development for these cases as they continue to fail to get before a jury in federal court. With only one more bellwether trial currently on the schedule, attention will likely shift to the second wave of bellwethers set to tentatively kick off in August 2026. Plaintiffs will look to have more success with those cases.
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October 20, 2025: Proposed Plan for Next Wave of Bellwether Trials Revealed
Abbott has proposed a plan for how the second wave of baby formula bellwether trials should be handled. The company is pushing for the first of three trials to begin in August 2026, with the other two following in November 2026 and February 2027. We should know soon if the judge overseeing these lawsuits will accept the proposal.
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October 17, 2025: Waiting on Results from Baby Formula Hearing
We are awaiting the outcome of a key hearing for the baby formula lawsuits that was on the schedule for this week. The hearing involves Abbott's motion for summary judgment in the next bellwether trial. If the judge were to rule in Abbott's favor, that would be a significant loss for the baby formula cases filed in federal court as they struggle to get before a jury. We will report back here on the judge's decision as soon as it is public.
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October 9, 2025: Key Baby Formula Lawsuit Hearing Coming Next Week
A key hearing that could impact hundreds of baby formula lawsuits is coming next week. The judge overseeing these cases will hear arguments on Abbott's summary judgment hearing for the next bellwether trial. Summary judgment is where Abbott asks the judge to rule in its favor before this case can go to trial.
The formula manufacturer is arguing that the lawsuit claiming it failed to warn its customers of an NEC risk from its product should not move forward because it would have made no difference. Abbott claims that there is no reasonable alternative to formula feeding in some cases and that a warning would not have changed doctors' decisions to feed formula to premature infants. This is a critical moment for this litigation after the judge awarded summary judgment in two previous bellwethers. -
October 2, 2025: Baby Formula Lawsuit Growth Mostly Flat
There are now 761 active baby formula lawsuits grouped together in federal court, which is an increase of just one case from this time last month.
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October 1, 2025: Second Wave of Bellwether Trials
The judge overseeing the baby formula lawsuits has directed both sides to come up with a schedule for a second wave of bellwether trials, with the first trial of this group to take place in August 2026. This move comes as bellwether trials in the current wave have so far failed to get before a jury, with the judge siding with formula manufacturers and awarding summary judgment in the first two cases.
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September 18, 2025: Summary Judgment Hearing for Bellwether Trial Coming Next Month
A hearing for Abbott's summary judgment motion on the upcoming bellwether trial has been scheduled for Oct. 14. This is a critical moment for the baby formula lawsuits. The judge overseeing these cases has already granted summary judgment to the defendants in the first two bellwether cases, meaning that she ruled in favor of the formula manufacturers before those cases could even get before a jury.
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August 2025
In a positive development for people who have filed lawsuits, the judge overseeing the baby formula litigation has excluded some of the expert testimony that the formula manufacturers planned to rely on in upcoming trials. Judge Pallmeyer found that one expert, who reported that there was not a “statistically significant” connection between baby formula and NEC, had committed an error and miscalculated some results. Another expert’s report was excluded due to their use of unexplained criteria.
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July 2025
In a significant loss for plaintiffs, Judge Pallmeyer has once again granted summary judgment to Abbott in an upcoming bellwether case. Both of the first two bellwether trials have now failed to get in front of a jury. While this is undoubtedly a blow, it's important to keep in mind that these cases have had far more success when they have made it to trial in state court. The next bellwether trial was scheduled for November.
Also this month, Judge Pallmeyer has ordered that a census form be completed for all cases involving Abbott Laboratories, including unfiled claims. The goal of the census is to better understand the number of claims against Abbott to help with negotiations of a potential settlement for these lawsuits. This doesn’t mean that a settlement is imminent, but according to Judge Pallmeyer, this can “promote the possibility of early resolution.” -
May 2025
In a blow to plaintiffs, the judge overseeing the baby formula cases has granted summary judgment to Abbott in the first federal bellwether trial. This means that Abbott has won the case before the trial could begin. More bellwethers are scheduled and Judge Pallmeyer cautioned that her decision has a "limited application" to the hundreds of other pending cases.
Judge Pallmeyer also dismissed attempts to exclude the testimony of plaintiffs' key experts from the upcoming trials. This is a big win for plaintiffs, allowing the MDL cases to move forward. -
March 2025
In a surprising win for plaintiffs, a judge has ordered a retrial in the only baby formula NEC lawsuit case that the defendants had won. That case, which had gone to trial in October, named both Abbott and Mead Johnson as defendants. The judge determined that "misconduct" committed by the defense team could have influenced the jury's final decision. Abbott and Mead Johnson are appealing the order.
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February 2025
The defendants in the baby formula MDL have filed for summary judgment, a move that could end much of the litigation in their favor before cases go to trial. As part of their argument, defendants have cited a recent NIH report supporting a theory that NEC is not necessarily caused by formula feeding, but by a lack of human milk. It's unclear how likely it is that the court would side with the defendants on this issue. Hundreds of millions of dollars have already been awarded to plaintiffs in similar cases that have gone to trial in state court.
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January 2025
There have been no major litigation updates over the last couple months. But 2025 is set to potentially be a big year for the baby formula lawsuits with the first bellwether trial in the MDL scheduled to begin on May 5. Two more 2025 trials are scheduled for August and November as well.
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October 2024
The latest state court baby formula trial has resulted in a victory for the defendants. A St. Louis jury sided with Abbott and Mead Johnson in a case where a mother of a premature infant who developed NEC had claimed that the companies failed to warn about the risks of the intestinal disease. This result is a bit of a shakeup, after two state trials earlier this year ended in huge verdicts for plaintiffs.
There was also some big news in the MDL earlier this month, with parties proposing a schedule for the four bellwether cases. The first trial is set to start on May 5, 2025, with the four trials running through February 2026. Judge Pallmeyer will need to approve the schedule. -
September 2024
We have seen some big progress towards the first MDL cases going to trial, with the order of the four bellwether trials now decided. Ericka Mar, as administratrix of the estate of RaiLee Mar v. Abbott Laboratories, is set to be up first. Judge Pallmeyer has directed counsel to set firm trial dates for these four cases.
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July 2024
More great news for plaintiffs who had a victory in court this month. A jury in St. Louis, Missouri awarded $495 million to the family of a baby girl who developed NEC after consuming Abbott premature infant formula in the NICU until 2021. The infant suffered irreversible neurological damage and will require long-term care. This is the second lawsuit to go to trial. The first trial was in March and ended in a $60 million verdict against Reckitt.
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June 2024
Judge Pallmeyer released a scheduling order, and we finally had an idea of when the first bellwether test trial could occur. According to court documents we’ve researched, the close of fact discovery should be in the early part of August 2024. Depositions and proceedings will follow as the litigation heads for trial.
The estimated start of the bellwether test trial will be in May 2025. Before this MDL bellwether, a trial in an Illinois state court yielded a $60 million verdict for a mother who lost her child to NEC. This verdict could signal positive things for plaintiffs in the first bellwether and across the other cases in the MDL. We’ve yet to see if the defendants want to continue to litigate or discuss a global settlement. -
May 2024
MDL Judge Pallmeyer ordered that plaintiffs must have specific evidence that an infant ingested a Mead Johnson product before naming the company as a defendant in the litigation. Evidence may include medical and feeding records from birth.
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March 2024
An Illinois jury ruled that Mead Johnson, a subsidiary of Reckitt Benckiser, must compensate the mother of a premature infant who died from an intestinal disease after being given the company's baby formula, Enfamil, with a verdict of $60 million.
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February 2024
Judge Rebecca Pallmeyer scheduled hearings that involved several plaintiffs on sealed/private motions for March 2024.
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December 2023
Four bellwether cases had been selected, but the start dates for the trials weren't confirmed. Lawyers expected the first trials might happen in 2024.
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April 2023
Lawyers continued to negotiate how the discovery was to be conducted.
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March 2023
The judge scheduled Science Day proceedings for May 3, 2023. Science Day allows the parties to present an overview of general medical and scientific issues to the court.
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December 2022
Defendants selected four cases for bellwether test trials: Clarke, Cresap, Inman and Mar.
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October 2022
The plaintiffs selected four bellwether test trials: Brown, Diggs, Lopez and Koeth. Randomly selected bellwether cases were McCarthy, Jacobs, Kelton and Donaldson.
There is also a separate class action MDL 3037 that we’ve found in Illinois for Abbott’s recalled infant formulas. This litigation is unrelated to the NEC formula lawsuits.
The two big plaintiffs’ verdicts we’ve seen in March and July 2024 will likely affect the litigation and bode well for plaintiffs. Brendan Smith, a mass torts and product liability lawyer with Simmons Hanly Conroy, told Drugwatch these verdicts are wins for plaintiffs.
“Considerable jury verdicts can significantly impact the litigation as a whole by setting legal precedents, influencing the strategies of both plaintiffs and defendants, and encouraging settlements,” Smith said.
While settlements or jury verdicts can impact the litigation as a whole, outcomes can differ in state court cases versus MDLs because different judges make decisions and unique experts provide evidence.
Cow’s Milk Baby Formula Brands
Enfamil and Similac cow’s milk baby formulas are the main brands included in lawsuits, but other manufacturers also make cow’s milk formulas that could have led to NEC. Premature babies fed baby formula were at a significantly higher risk of developing NEC than those fed human milk exclusively, according to an observational study published in Neonatology.
Another study published in The Journal of Pediatrics found that the risks of developing NEC were lower in breastfed babies than in those fed a combination of mother’s milk and infant formula.
Current litigation defendants are Abbott (Similac) and Mead Johnson/Reckitt (Enfamil), but we’ve included other brands of cow’s milk formulas discussed in litigation on this list.
- Avacare
- Baby’s Only
- Bobbie
- Earth’s Best
- Enfamil
- Gerber
- Happy Baby
- Holle
- Lebenswert
- Loulouka
- Kendamil
- Parent’s Choice
- PediaSure
- Similac
Mead Johnson and Abbott Laboratories products Enfamil and Similac have no warnings about NEC as a side effect of baby formula or proper instructions or guidelines for their use, according to parents who filed a Similac or Enfamil lawsuit. The companies also marketed their products as safe and beneficial for premature infants despite the potential risks.
Parents are suing for extensive financial losses and emotional distress related to their baby’s injuries or death.
Have Enfamil and Similac Formulas Been Recalled?
No Similac or Enfamil recalls have been issued specifically for NEC risk, but there were isolated store recalls for product tampering and a 2022 recall for bacterial contamination.
The tampering incident came to light when a few mothers reported that their Enfamil products contained flour instead of formula. In another incident, babies got sick and some died after drinking Enfamil which reportedly caused bacterial infections. The FDA tested the formula and declared it safe.
In February 2022, Abbott Nutrition issued a baby formula recall for certain lots of Similac, EleCare and Alimentum manufactured at its Sturgis, Michigan, facility after four babies suffered Cronobacter sakazakii infections and one baby became infected with Salmonella Newport. Two of the babies died.
The FDA released a preliminary inspection report in March 2022 that said that Abbott didn’t have “a system of process controls” in place to “ensure that infant formula does not become adulterated due to the presence of microorganisms.”
In June 2022, the FDA received an additional report of an infant death that could be related to bacterial contamination. The same month, Abbott’s Sturgis plant reopened to help ease the baby formula shortage caused in part by the recall.
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