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Nutramigen Infant Formula Recall: Will Lawsuits Bang in 2024?

by | Feb 3, 2024 | Product liability

In a world where breast milk is celebrated for its unparalleled benefits, the question arises: what role does baby formula play in infant nutrition? In this age of innovation and convenience, baby formula is an ingenious development that provides essential nutrients for babies unable to be breastfed or when it’s not an option. In the United States, where choices seem boundless, parents are faced with an excess of options, each claiming to offer the best start for their little ones. From glass bottles filled with condensed milk to the highly specialized, scientifically formulated blends available today, the landscape of baby formula has evolved tremendously over the years. Beyond convenience, baby formula plays a pivotal role in addressing various health and lifestyle factors that influence infant feeding choices in American households.

Through this blog, we are exploring the dark world of baby formula, Nutramigen powder baby formula lawsuits. Before going deep, let’s understand the different types of formula available in the U.S. market.

Types of Infant Formula

In general, any formula brand could be either a dry powder that needs to be mixed up with water, or a ready-to-feed liquid formula. Let’s have quick glance on different types of formula based on the composition and usage.

  • First infant formula – Based on whey protein which is easily digestible.
  • Goats’ milk formula – Goat milk-based formula with less tendency for allergic reactions.
  • Hungrier baby formula– Contains more casein than whey.
  • Anti-reflux (staydown) formula– Thickened formula to prevent reflux in babies.
  • Comfort formula– Contains cows’ milk proteins that is partially hydrolyzed.
  • Lactose-free formula– Contains no lactose and is suitable for lactose intolerant infants.
  • Hypoallergenic formula– Contains fully hydrolyzed proteins.
  • Follow-on formula– Suitable for babies from 6 months.
  • Soya formula– Based on soya milk, not cow’s milk.
  • Growing-up milk (toddler milk) – Suitable for babies from 1 year.

What is Nutramigen?

Nutramigen is the product of Mead Johnson & Company, LLC, an American company. Mead Johnson is a leading manufacturer of infant formula. The company was created by Edward Mead Johnson, one of the co-founders of Johnson & Johnson. In JUNE 2017, Reckitt Benckiser Group plc. acquired Mead Johnson Nutrition Company and currently it operates as an independent subsidiary of Reckitt.

Nutramigen is the baby formula product of Mead Johnson, specially formulated for babies and toddlers allergic to soy and cow’s milk protein. Nutramigen formula is an iron-enriched, hypoallergenic baby formula.

As per the brand, the following are the product features

  • Helps reduce the likelihood of other allergic manifestations at 3 years of age
  • Helps infants return to cow’s milk easier
  • Has the probiotic LGG to help support the strength of the intestinal barrier and support digestive health and immune health
  • Hypoallergenic protein source with hydrolyzed casein
  • Expert-recommended DHA at 0.32% of total fatty acids, the same amount as the worldwide breast milk average
  • Has no sucrose
  • Lactose-free
  • No artificial growth hormones in the product

Nutramigen Controversy 2024

Parents around the country started to complain in November 2023 about having trouble locating Nutramigen formula on store shelves. Nutramigen shortages were especially tough on families who had infants with severe allergies to cow’s milk proteins and could not find any other formula alternatives.

Is there a recall on Nutramigen formula?

This was the concern of many parents which became true at the end of 2023.

Nutramigen Infant Formula Recall

On December 30, 2023, Reckitt/Mead Johnson Nutrition (MJN) officially announced the recall of few batches of its Nutramigen Hypoallergenic Infant Formula Powder. The recall covers over 657,000 cans of infant formula. The company stated that the recall affects Nutramigen Powder 12.6 and 19.8 ounce cans sold in the United States.

nutramigen-infant-formula-recall-fda-notice

The recall involves Nutramigen in 12.6 ounce cans with batch codes ZL3FHG, ZL3FMH, ZL3FPE, ZL3FQD, and ZXL3FXJ and also 19.8 ounce cans with batch code ZL3FRW.These recalled cans of infant formula have a UPC code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

Let’s check out the details of the recalled batches below.

nutramiden-infant-formula-recall

Parents and caregivers who use Nutramigen for their babies should check the batch codes mentioned above to see if their formula is being recalled.

What was the reason behind Nutramigen recall?

The FDA was notified on December 14, 2023, by the Israeli Ministry of Health that Nutramigen formula had tested positive for Cronobacter, which was tested as part of their routine sampling. The formula tested positive was imported from a Mead Johnson facility in Zeeland, Michigan.

Following the reports from Israel, the FDA did a detailed investigation, with an inspection at the Zeeland facility, and collecting environmental samples. Samples of the formula from the same batch that was shipped to Israel were also tested by officials.

Israel started testing the sample again at the same time, and the results validated their findings. The FDA was informed by Israeli health officials on December 28. After a day, Reckitt/Mead Johnson Nutrition consented to the 675,030 cans’ voluntary recall.

As per MJN, the recall was due to a “possibility of contamination with Cronobacter sakazakii.” The recalled product was manufactured in June 2023 and distributed between June and August 2023. The recall was triggered by the tainting of an oversees sample.

The company in the recall message also assured that “all product in question went through extensive testing by MJN and tested negative for the bacteria.”

As per the FDA, Nutramigen recall does not have a huge impact on the formula supply or availability in the U.S.

How Do I Know if My Formula Is Affected?

The affected Nutramigen Hypoallergenic Infant Formula Powder comes in 12.6 and 19.8-ounce cans. It was manufactured in June 2023 and was distributed between June and August 2023 at stores across the country.2

Cronobacter sakazakii- What is it?

Cronobacter sakazakii, formerly known as Enterobacter sakazakii is a pathogenic bacteria that can cause illness, especially in infants. It is a rod-shaped, opportunistic, Gram-negative bacteria that has xerotolerance, which is the ability to survive in extremely dry environments. The use of powdered infant formula has been linked to the majority of cases of neonatal C. sakazakii infections, with some strains able to survive in a desiccated state for more than two years. Not every case, though, has been connected to tainted baby formula.

Cronobacter sakazakii infections are especially seen in infants under two months’ old, premature babies, infants with compromised immune systems, and low birth weight babies. Even though Cronobacter infections are uncommon, they can be fatal for immunocompromised newborns.

The notable point is that the same bacteria had caused previous baby and infant formula recalls including the Abbott recall that resulted in the closure of the company’s Sturgis, Michigan facility in 2022.

Symptoms of Cronobacter Infection in Babies

What are the Cronobacter infection symptoms in infants? Let’s check it out.

  • Poor feeding response
  • Grunting while breathing
  • Irritability and crying
  • Jaundice
  • Unstable body temperature

A Cronobacter sakazakii infection can also become meningitis, which is the inflammation of the membranes surrounding the brain and spinal cord. Symptoms in such cases would be:

  • High fever and seizures
  • Constant crying
  • Excessive sleepiness or irritability
  • Sluggishness and Poor feeding
  • A bulge in the soft spot on the top of the head
  • Stiffness of the body and neck

How does Cronobacter sakazakii get in Nutramigen formula?

Baby formula can become contaminated at processing facilities or in homes by Cronobacter sakazakii, according to the Centers for Disease Control and Prevention (CDC). For example, Cronobacter could get into the formula if: Placing formula lids or scoops on contaminated surfaces, like countertops or sinks etc., can cause contamination. Contamination in the processing facilities can also take place due to improper pasteurization of the constituents and end product, cross-contamination and also due to unsterile processing units.

To prevent contamination at home, the CDC advises breastfeeding, cleaning hands and surfaces, sanitizing bottles and other feeding supplies, and storing formula properly.

The Response of Reckitt / Mead Johnson to the Recall

“Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed. There are no reports of illnesses or adverse events to date.”

“We are committed to the highest level of quality and safety and it is for this reason that we have taken this measure,” Reckitt/Mead Johnson Nutrition says in a press release posted on the FDA’s website. “The health and safety of infants is our highest priority. All of our products undergo rigorous and industry-leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies.” – says Mead Johnson.

Though there were no reports of tainting in the product, Reckitt/Mead Johnson Nutrition decided to recall a few batches of Nutramigen as a precautionary measure, given the critical responsibility of providing safe nutrition to infants who are particularly vulnerable.

With confidence, parents who use Reckitt/Mead Johnson Nutrition products, such as the powder formula Nutramigen, can continue to safely feed their infants.  Reckitt’s liquid formulas and other nutrition products are unaffected by this recall, the company guarantees.

What should I do if I have a recalled product?

As per the recall notice issued by the company, consumers who purchased Nutramigen should check the bottom of the can to identify whether the product belongs to the batch number that is affected. If the product belongs to the recalled batch, it should not be used. The company had agreed to issue a total refund to consumers who purchased the recalled cans.

Consumers can contact the company at 866-534-9986, 24 hours a day, seven days a week or by email at [email protected] to verify if this product was impacted.

Parents and caretakers are advised to inspect the infant for any symptoms if they have been giving the recalled batch of product. For any medical emergency, parents should seek medical attention for the child. To switch the formula to another brand, parents and caretakers should consult an expert pediatrician.

The Role of the FDA in Nutramigen Recall and Regulation

The FDA has developed a Cronobacter prevention strategy, strengthened inspectional activities, stepped up engagement with the infant formula industry, and pursued regulatory actions to improve the safety of powdered infant formula.

The agency also sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers who are involved in the production and distribution of Nutramigen.

Can I file a Nutramigen infant formula lawsuit?

The answer is yes, provided you are affected by the recalled product of Nutramigen. Families who may have been impacted by this recall and who suffered harm or distress as a result of using the recalled baby formula may be able to pursue legal action through a product liability lawsuit.

There are no product liability lawsuits yet against Reckitt and Mead Johnson Nutrition for Nutramigen recall or side effects. However, Nutramigen infant formula lawsuits may boom in 2024, where Reckitt and Mead Johnson would be accountable for producing and distributing a product with potential contamination that could harm infants.

It is recommended that victims or their families seek the advice of a knowledgeable product liability lawyer who has handled cases involving defective products. To obtain proof for the allegation, the lawyer would launch a thorough investigation. To build a strong case, this entails gathering witness statements, expert opinions, medical records, and product documentation.

The lawyer files a product liability lawsuit against the manufacturer if the case has a good basis. During the discovery phase, both parties exchange documents, evidence, and information pertinent to the case.

A settlement agreement may result from discussions between the parties in many situations. In the event that a settlement cannot be reached, the matter may go to trial and be decided by a jury or judge.

In a case of successful product liability lawsuit, the following damages may be covered.

  • Medical Expenses
  • Pain and Suffering
  • Lost Income

If you or a loved one has suffered due to the consumption of the recalled Nutramigen Hypoallergenic Infant Formula Powder, consider reaching out to a qualified product liability attorney who can provide guidance and support throughout the legal process.

Role of Medical Record Reviews

Medical record reviews also play a vital role in supporting these lawsuits. They provide essential documentation and evidence of the harm caused by unsafe baby formula, helping parents build a strong case. Medical chronologies, narrative summaries, and expert medical opinions can all contribute to establishing the link between the formula and the health issues faced by the child. By seeking legal recourse and utilizing medical record reviews, parents can strive to ensure justice and protect the well-being of their precious little ones.

Medical record reviews can play a crucial role in unsafe baby formula lawsuits by providing evidence and insights that support the plaintiff’s case. Here’s how they can help prove such cases:

Medical record reviews can reveal if a baby suffered health issues directly related to the consumption of the formula. This includes all the symptoms listed previously. If multiple cases show similar health issues following the use of the product, it strengthens the argument that the formula was unsafe.

Expert medical opinions can mirror the health risks associated with the formula, based on their analysis of the records and their expertise in the field. Medical records review can also provide evidence of the medical costs incurred due to the baby’s health issues, such as hospital bills, doctor’s visits, medications, and therapies. These costs can be used to calculate damages in Nutramigen infant formula lawsuit.

Medical record reviews can complement other evidence, such as FDA reports, product recalls, or safety alerts related to the formula. If the formula in question has a history of safety issues, this can strengthen the case against it. Each case is unique, and the success of the lawsuit depends on the specific circumstances and evidence available.

Need High Quality Medical Record Review?

To wind up, ensuring the safety of the baby formula you choose for your little one is paramount. Parents must stay vigilant and informed about the products they rely on to nourish their infants. Keeping an eye on recalls, product quality, and ingredient lists is crucial. Additionally, consulting with pediatricians and other healthcare professionals can provide valuable insights into selecting the right formula for your baby’s specific needs.

When it comes to addressing the financial burdens that may arise from unsafe Nutramigen formula dangers, lawsuits can play a significant role. Nutramigen lawsuits can help parents seek compensation for medical expenses, emotional distress, and other damages caused by using unsafe products. Manufacturers have a responsibility to ensure the safety of their products, and lawsuits can hold them accountable for any negligence or harm they cause.

Let’s wait how Nutramigen recalls proceed. Will Nutramigen lawsuits boom? 2024 will answer. Stay tuned with us for more updates on Nutramigen infant formula lawsuits 2024 and also NEC lawsuits.

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