Baby Formula Controversies, Risks & Industry Failures

Infant formula plays a big role in providing essential nutrients for infants, especially when breastfeeding isn’t an option. Formulas are often fortified with beneficial ingredients to nourish infants, such as iron, vitamins and minerals.

According to the Food and Drug Administration, many infants rely on baby formula for some or all of their nutritional needs.

But concerns over safety, contamination and the risk of serious health issues have led to baby formula lawsuits.

Research has established a link between some cow’s milk-based formulas and necrotizing enterocolitis (NEC) in premature infants. NEC is a serious and potentially fatal intestinal condition where bacteria can inflame and infect intestinal tissue, leading to perforation and infection.

There are currently hundreds of pending lawsuits alleging that baby formula manufacturers Abbott Laboratories and Mead Johnson failed to warn parents of potential NEC risks associated with some of their cow’s milk formulas.

The Link Between Baby Formula & Necrotizing Enterocolitis (NEC)

For years, research has suggested that a link may exist between formula feeding and NEC. According to Cleveland Clinic, 90% of infants who develop NEC are born prematurely. About one in 1,000 prematurely born infants go on to develop the condition.

Still, there continues to be debate over what risk factors play the biggest roles in the development of the condition, but feeding remains widely regarded as a key indicator.

A 2018 critical analysis of NEC risk factors consulted 35 NEC experts and asked them to review 64 different potential risk factors. From that list, formula feeding vs. breastfeeding was one of just three NEC development risk factors that experts highly agreed on.

According to Children’s Hospital Los Angeles, the condition typically occurs within the first two weeks of life in premature infants who are fed specific formulas.

Not every type of baby formula is tied to NEC. Concerns generally involve certain cow’s milk-based formulas.

While treatable, NEC can be a very serious issue, sometimes resulting in permanent disability or even death. The mortality rate generally ranges from 10% to 50%.

How Baby Formula Recalls Exposed Safety Issues

In addition to the potential threat of NEC, contamination issues and baby formula recalls have fueled health concerns surrounding infant formula.

In 2022, several Abbott formulas were recalled following reports of Cronobacter infections. According to the Centers for Disease Control and Prevention, Cronobacter is a germ that can survive in dried foods like baby powder.

When it infects infants, it can be fatal, as it may lead to the development of meningitis. At the time of the baby formula recalls, four hospitalizations and two deaths had been reported.

What Are the Long-Term Health Risks of Contaminated or Unsafe Formula?

The effects of unsafe baby formula can be wide-ranging and potentially devastating.

Contaminated formulas that contain germs like Cronobacter can be potentially fatal to infants. According to the CDC, early signs of Cronobacter infection in infants can include a fever, low energy and excessive crying.

It can eventually cause meningitis, a condition in which the meninges, the linings of the brain and spine, begin to swell. Even non-fatal infections can cause serious and long-term issues in the brain.

Similarly, NEC can also be fatal or cause long-term, potentially irreversible damage. Cleveland Clinic reports that symptoms of the condition are often abdominal swelling, bloody stool and changes in heart rate, breathing or blood pressure.

Some infants require surgery due to the effects of NEC, with it becoming necessary to remove dead tissue from the abdomen.

Multiple studies have shown that cow’s milk-based formulas may result in a heightened risk of developing the serious condition.

According to a 2022 study published in Frontiers in Pediatrics, “Formula feeding is an important risk factor for the development of necrotizing enterocolitis in preterm infants.” However, the study cautions “The potential harmful effects of different preterm formulas on the developing intestinal tract remain incompletely understood.”

What Studies Have Found About Formula & NEC

In the Frontiers in Pediatrics study, researchers noted “alterations in gut microbial composition” along with gut injury, inflammation issues and apoptosis” when mouse pups were fed different types of formula.

A 2017 review published by the American Society for Nutrition determined that feeding cow’s milk formulas to premature infants “significantly increases the risk of NEC.”

Research shows that premature infants fed only breast milk experience lower rates of NEC. What remains unclear is exactly why this potential connection exists. Additional research can help medical providers and parents better care for preemies.

Why Did Manufacturers Continue Selling Formula Despite NEC Risks?

The makers of Similac and Enfamil have continued to push back on claims that their formulas are linked to the development of NEC, even as some juries have awarded multimillion-dollar verdicts to the families of infants who developed the condition.

“There is no scientific evidence showing Abbott’s preterm infant products cause or contribute to causing NEC,” Abbott spokesperson Scott Stoffel claimed following a 2024 trial loss, per KMOV. “Specialized formulas and fortifiers, like the one in this case, are part of the standard of care by the medical community and, along with mother’s milk and donor human milk, are the only available options to feed premature infants.”

Though Abbott and Mead Johnson have recalled formula products, no recall was issued due to specific NEC concerns. The companies publicly maintain that their products are not associated with NEC risks.

After an NEC trial verdict in Mead Johnson’s favor, the company released a statement saying, “Where human milk is unavailable or when supplementation is necessary, specialized preterm hospital nutrition products can provide essential, lifesaving nutrition.”

What Did Baby Formula Manufacturers Know About NEC Risks?

According to Bloomberg, a plaintiff lawyer in one baby formula trial claimed that internal documents showed that Abbott officials had privately acknowledged that formula feeding was connected to NEC as early as 2009.

Both Similac and Enfamil publicly reject claims that their formulas are tied to NEC.

The companies also focused on aggressive marketing of their products, helping to ensure that they were supplied in hospitals and NICUs.

According to CNN, experts say that formula companies’ marketing strategies have undermined breastfeeding practices with an emphasis on getting formula to mothers before they leave the hospital. This has included offering free formula to hospitals.

Contamination & Manufacturing Failures at Abbott Labs

During the 2022 recall of specific Abbott formulas, one of the main points of contention involved practices at its major formula manufacturing facility in Michigan, which was temporarily shut down in February 2022.

According to the New York Times, the shutdown was triggered by the discovery of serious issues, including cracks in production equipment, a leaking roof and standing water pooled on the floor. The plant remained closed for more than four months.

According to CBS News, a whistleblower sent an email to the FDA in early 2021, calling attention to issues in the facility, but an FDA employee accidentally archived that complaint. Ultimately, it took it took more than 100 days for the FDA to inspect the plant after a separate whistleblower complaint was sent in October 2021.

Though the FDA does not directly approve infant formulas, it does issue regulatory requirements for various activities, including the labeling and packaging of formula products. However, it has not had a significant response to potential links between NEC and certain kinds of formulas.

Still, other government entities have warned of the potential risks. In 2011, the U.S. Surgeon General released a call to action highlighting NEC’s possible ties to baby formula in a call to action to support breastfeeding.

The report noted that formula feeding for premature infants is associated with a higher risk of NEC.

Have Federal Investigations Been Launched Into Baby Formula Safety?

The federal government has launched several investigations into baby formula safety, largely in response to the recall, shortages and factory shutdown in 2022.

According to the Washington Post, the Justice Department opened a criminal investigation in January 2023 into the Abbott facility that was shut down for several months following numerous issues.

Congressional hearings were also held over the nationwide infant formula shortage, which was due in part to the Similac recalls and shutdown of the Michigan plant.

In the wake of those developments, experts have also called for stricter regulation of infant formula. In February 2023, experts from institutions across the globe published a three-paper series in The Lancet, a medical journal, highlighting concerns about the exploitative marketing of infant formula products and the need for change, among other related concerns.

In March 2025, the U.S. Department of Health and Human Services and the FDA announced Operation Stork Speed. The initiative is intended to ensure the safety, quality, availability and nutritional adequacy of baby formulas.

FDA actions include reviewing nutrients, increased testing for heavy metals and contaminants, encouraging more communication with manufacturers, encouraging more research on the outcomes of formula feeding and communicating with consumers to ensure transparency.

Despite the risks and concerns tied to some types of infant formulas, formula as a whole remains a critical product for infant nutrition. Millions of infants in the U.S. are fed formula every year, and breastfeeding isn’t always a feasible option for families. Safe infant formulas can help meet infant nutritional needs.

What Are the Safest Baby Formula Options?

To find the safest baby formula option for your family, look for brands that are highly reputable, check for recalls and read about potential side effects or issues from different sources.

According to the New York Times, experts say formulas that include lactose as the only carbohydrate can be particularly healthy options for infants. Formulas with extra nutritional ingredients can also be effective.

Infants who cannot be breastfed or have cow’s milk allergies may benefit from a hydrolyzed formula. In this type of formula, milk proteins are already partially broken down for an easier digestion process.

These formulas may also help alleviate stomach issues in infants.

Has the Baby Formula Industry Changed Its Safety Practices?

Safety has improved in the infant formula industry, particularly following the recalls and shortages of 2022.

Following the closing of the Michigan facility, the FDA implemented numerous changes to its inspection process and standards for infant formula facilities.

A new process for notifying Congress about infant formula recalls was implemented. Particular emphasis was placed on preventing Cronobacter contamination and infection, with the FDA altering or implementing a number of policies to improve testing and detection.

If you suspect that your infant may have been harmed after being fed formula, consider reaching out to a lawyer who has experience with baby formula litigation. Hundreds of lawsuits have been filed by families and parents of infants affected by NEC.

Lawyers continue to investigate and accept new cases as the litigation progresses.

How to Tell If Your Baby Was Harmed by NEC or Contaminated Formula

NEC primarily affects premature infants, and its symptoms can vary depending on the severity of the case. Signs of NEC can include diarrhea, blood in stool, poor feeding tolerance, lethargy and a swollen, bloated or discolored stomach.

If your infant is in the NICU, the staff will likely inform you if your child has developed NEC. If you notice signs of NEC while your child is at home, seek medical care immediately.

The condition is generally diagnosed through X-rays, blood tests or fecal tests.

Contaminated formula can lead to a Cronobacter infection. According to the FDA, jaundice, grunting breaths, temperature changes and abnormal body movements may all be signs of Cronobacter infection in an infant.

The initial identification of health complications stemming from contaminated formula may fall on the parents since these conditions can emerge when the infant is already living at home.

What to Do If You’re Concerned About Your Baby’s Formula

If you’re concerned about your baby’s formula, start by checking its expiration date and consulting the FDA’s website to determine if it’s part of a recall.

Always inspect the container for damage, unusual smells or changes in texture. If your baby shows signs of discomfort, such as vomiting, diarrhea or refusal to eat, consult your pediatrician.

If your infant is experiencing symptoms of NEC or Cronobacter, seek medical care as soon as possible.