Why Do Baby Formula Recalls Keep Happening?

There have been so many recalls in the past few years, but now the FDA is stepping up oversight of formula manufacturers.

Medically reviewed by Wendy L. Hunter, M.D.

The Food and Drug Administration (FDA) is stepping up oversight of infant formula manufacturers. This comes in the wake of several major recalls over the past few years.

In a news release from August 30, 2023, the FDA said it sent warning letters to three baby formula companies after recent inspections. The letters were sent to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. All three of these manufacturers had recalls in late 2022 or early 2023.

The FDA says the letters are part of its normal process to reinforce to the companies how critical it is to correct the safety issues related to the recalls. That includes finding the cause of the contamination and making sure to properly clean and sanitize.

If the name Perrigo sounds familiar, it's because in May 2023, the company recalled certain lots of Gerber Good Start SoothePro powdered infant formula—manufactured at the company's Eau Claire, Wisconsin facility. The reason is it could contain traces of the Cronobacter sakazaii. That's the same bacteria you keep hearing about with all these recent recalls.

"Cronobacter sakazaii is a hardy germ that is known for surviving processing and, therefore, can persist in dry infant formula," explains Christina Johns, MD, MEd, FAAP, a pediatric emergency doctor and senior medical advisor at PM Pediatric Care. "While it doesn't always cause disease in infants, it can cause meningitis, blood infections (sepsis), and necrotizing enterocolitis (where part of the intestine is damaged), which are very serious illnesses that can be fatal."

The affected formula was manufactured between January 2-18, 2023, and sold after March 5, 2023. If you have Gerber Good Start SoothePro formula, you can check the lot numbers below against your can and reach out for a refund.

For many parents, infant formula is your baby's primary source of nutrition. Although the Food and Drug Administration (FDA) works hard to ensure manufacturers are adhering to strict safety protocols, there are times when contamination occurs. Because your baby can get very sick from drinking contaminated formula, this might leave you feeling a little concerned about the safety of formula in the United States.

Why Does This Keep Happening?

Since February 2022, there have been multiple recalls on infant formula, including everything from Nestle and Gerber to Similac and Enfamil, many of which were recalled because of concerns over Cronobacter sakazaii. Not surprisingly, you may be wondering why this keeps happening and if it has something to do with how infant formula is manufactured.

"There isn't a simple answer to these questions, as it is a combination of factors that make powdered formula a vehicle for Cronobacter sakazaii infection in infants," says Brian Labus, PhD, MPH, REHS, an expert in infectious diseases and an assistant professor in the department of epidemiology and biostatistics at the UNLV School of Public Health. "Contamination can occur because the organism can be found throughout the environment."

While there is limited research on the frequency of contaminants like this getting into powdered formula, what we do know about Cronobacter is it can survive extended periods of time in very dry conditions, Dr. Labus says. Normally, a cooking step kills contaminating bacteria, like with flour, for instance. But infant formula is not cooked.

"Powdered formulas in particular can be susceptible to contamination," says Jenelle Ferry, MD, a board-certified neonatologist at Pediatrix Neonatology of Florida at Pediatrix Medical Group. "These formulas are not sterile."

Even though powdered infant formula isn't required to be sterile, there are regulations in place that require manufacturers to go to great lengths to eliminate all sources of contamination during the production process.

"The recent recalls have all occurred out of an abundance of caution to try and prevent these rare yet potentially life-threatening infections," Dr. Ferry adds. "In the majority of recalls, the bacteria was not found in the formulas themselves. In most cases, the recalls were specific to a single manufacturing facility or single product batch for these companies, and not all formula products. Because contamination is a known potential risk [when preparing] powdered formulas, parents should be most concerned about following safe preparation practices."

Ensuring the Safety and Supply of Infant Formula

On March 28, 2023, the Food and Drug Administration (FDA) along with other federal partners released a national game plan to help ensure the safety and supply of infant formula. The goal is to help avoid the recalls and shortages we've been seeing since 2022.

Here are some of the steps they are taking:

• Increase the number of baby formula options and strengthen the supply chain.

• Enhance inspections at infant formula manufacturers, including improved training for investigators.

• Track supply of infant formula.

• Build up the Department of Agriculture's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

• Advance the FDA's strategy to prevent cronobacter sakazakii illnesses associated with powdered infant formula.

• Improved resources for parents and caregivers both online and through their health care providers.

• Work with Congress to create an "Office of Critical Foods" to monitor critical food products such as infant formula.

Related: Is the Formula Shortage an Opportunity for Access to Better Quality Formula?

How to Prevent Contamination at Home

Many times, contamination of infant formula occurs at home after the formula has been opened and then during re-use, rather than during manufacturing, Dr. Ferry says. "There was recently also a case reported which was thought to be from contaminated breast pump parts. [But] the majority of cases have been reported in infants fed powdered formula."

While Cronobacter is not a common contaminant, according to the Centers for Disease Control and Prevention (CDC), if an infant has this type of infection it is most likely from infant formula, says Sarah Adams, M.D., FAAP, a pediatrician at Akron Children's Hospital.

In fact, of the infections that do occur in babies, more than 90% have been linked to powdered infant formula. But the contamination causing these illnesses is not limited to manufacturing. In fact, your baby's formula also can get contaminated during storage and reconstitution of the powdered formula.

"Cronobacter can live on surfaces in the home such as counters and sinks and in the water, for example," Dr. Adams says. "[Your] formula can become contaminated from the bacteria if the lid or scoop touches a contaminated surface or from mixing the formula in contaminated water."

To keep your formula free of contaminants, start by safely preparing and storing your formula. You also should clean and sanitize your feeding items as well as wash your hands and keep surfaces clean.

"Do not place lids and scoops on counters or in sinks and take precautions to prepare the formula safely with sterile or boiled water and close the lid as soon as possible," Dr. Adams says. "[Also] talk to your pediatrician if your infant is at high risk for infection such as infants with poor immune systems or those who are premature."

Related: An Age-by-Age Feeding Chart for Babies and Newborns

Can I Give My Baby Recalled Formula?

If the specific infant formula you use has been recalled, better to be safe than sorry and not give it to your baby.

"If you have a recalled formula in your home, it is not safe to give it to your baby because of the potential risk for contamination," says Dr. Adams. "Cronobacter can live on surfaces so if you have a can of the recalled formula throw it away if it is open. If it is not open, check with the store you bought it for a refund or throw it away."

You should also make sure to reach out to your baby's health care provider if they've already been given the recalled formula so they can watch for any possible symptoms, and you can talk to them about any concerns you have,

"If a product is involved in a recall, it may not necessarily be contaminated, although its safety cannot be guaranteed."

Jenelle Ferry, M.D.

"If a product is involved in a recall, it may not necessarily be contaminated, although its safety cannot be guaranteed," adds Dr. Ferry.

With the most recent recall, Perrigo says none of the distributed products have tested positive for Cronobactor. Plus, the company says there have been no adverse reactions and no other products have been impacted.

That said, if you purchased Gerber Good Start SoothePro formula in March and want to see if your formula is included in the recall, you can call the company (1-800-777-7690) with your lot number and use by dates to see if you are eligible for a refund. You also should stay in close contact with your child's health care provider to get the best individual guidance, especially if you are concerned about your baby's formula, Dr. Jones says.

"Government agencies also will initiate investigations if there are safety alerts, so parents shouldn't be consumed with worry that they're missing something," she says. "Paying attention without panic is the best approach."

If you are particularly concerned, consider using a liquid formula instead. Just be sure to touch base with your pediatrician before switching formulas. They can advise you on the best options to meet your child's unique nutritional needs.

Related: The Difference Between Powder, Concentrated Liquid, and Ready-to-Use Formulas

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