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          Infant FormulaResources for You (Food) Infant Formula
  
  	
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What’s New

January 10, 2024

Products produced during the same finished product campaign as the U.S.-recalled product were distributed in at least the following countries: Argentina, Belgium, Belize, Canada, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Ireland, Israel, Jamaica, Mexico, Nicaragua, Peru, Poland, Spain, United Kingdom, and Venezuela. Reckitt/Mead Johnson Nutrition has indicated to FDA that the company has already contacted the regulatory authorities in each of the countries to determine the proper disposition of these products.

December 31, 2023

On December 28, 2023, the FDA received information concerning a confirmatory analysis for a *Cronobackter sakazakii*positive finding in Nutramigen, a hypoallergenic powdered infant formula product manufactured by Reckitt/Mead Johnson Nutrition. The Israeli Ministry of Health identified the positive finding during routine sampling during import operations. The FDA has initiated an inspection at the Reckitt/Mead Johnson Nutrition Zeeland, MI facility and Reckitt/Mead Johnson Nutrition is voluntarily recalling certain Nutramigen Hypoallergenic Infant Formula Powder products due to possible *Cronobacter sakazakii*contamination.

The voluntarily recalled Nutramigen product was manufactured between June 6, 2023, and June 29, 2023, and includes batch numbers: ZL3FHG (12.6 oz cans), ZL3FMH (12.6 oz cans), ZL3FPE (12.6 oz cans), ZL3FQD (12.6 oz cans), ZL3FRW (19.8 oz cans), and ZL3FXJ (12.6 oz cans). The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025. Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products. There are no known illnesses associated with this product to date, and likely most of the product that was distributed in the U.S. has already been consumed. Consumers who have Nutramigen Powdered Infant Formula with the above batch numbers should stop using it and throw it away.

Additional information on the recall is available:

Constituent Update: Reckitt/Mead Johnson Nutrition Voluntarily Recalls Certain Nutramigen Hypoallergenic Powdered Infant Formula Products
	Recall Announcement
	Government of Canada Recall Announcement


Many infants in the U.S. rely on infant formula for some or all of their nutrition. Ensuring that the youngest and most vulnerable individuals have access to safe and nutritionally adequate formula products is a top priority for the Food and Drug Administration (FDA). The agency oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them. The agency also works with multiple partners in public health to ensure that parents and caregivers have the latest information regarding safe preparation of infant formula and to answer questions regarding the safety and nutritional quality of formula. In addition, the FDA is working on a number of fronts to support the availability and resiliency of the infant formula market.

**On this page:**

How does the FDA oversee the safety and nutritional quality of infant formula?
	Advice for Parents and Other Caregivers
	Safe Preparation and Feeding of Formulas
	Information for Infant Formula Manufacturers
	Latest News
	Additional ResourcesWomen looking at cans on infant formula on a grocery store shelf
How does the FDA oversee the safety and nutritional quality of infant formula?

Infant formulas are intended for children up to 12 months of age. The FDA regulatory requirements address the safety, nutritional adequacy, packaging, and labeling of these products. The FDA does not approve infant formulas; however, infant formula manufacturers must notify the agency before marketing a new formula. FDA’s highly trained staff review these notifications to make sure new formulas meet federal nutrition, labeling, and other requirements. If a product does not meet applicable requirements, the formula may be deemed adulterated, misbranded, or both, and the FDA has the authority to take enforcement action if it is marketed. Federal law permits the FDA to require a mandatory recall if the agency determines that an adulterated or misbranded infant formula presents a risk to human health.

Among the requirements for infant formulas, the FDA specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients. In addition, any ingredient used in infant formula must be safe and suitable for such use. Controls are required by law to prevent contamination and other problems from happening. For example, manufacturers must establish a system of controls designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. Further, FDA regulations set forth certain testing requirements of finished product for *Salmonella*and *Cronobacter*. The FDA also makes sure that the water the companies use to manufacture formulas meets safety standards set by the U.S. Environmental Protection Agency.

The FDA has specific requirements for labeling infant formulas. Information that is most helpful for caregivers of infants includes: directions for preparation and use, a pictogram showing the major steps for preparing infant formula, use by date, and instructions indicating whether water should be added.

The FDA inspects facilities that manufacture infant formulas annually and carefully trains its investigators to ensure that every infant formula inspection is robust, thorough, and focused on the most critical aspects of the infant formula manufacturing process. The FDA has also taken, and continues to take, multiple steps to improve the resiliency of the infant formula supply, including the temporary exercise of enforcement discretion, which are described in the agency’s Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. Some of this work includes working with manufacturers, who are now required to have risk redundancy plans, to help ensure a stable and consistent supply of infant formula.

In 2022, safety concerns with powdered infant formula led to a voluntary recall of specific lots of powdered infant formula manufactured at an Abbott Nutrition facility in Sturgis, Michigan. Since then, the agency has taken steps to enhance the safety of powdered infant formula through the development of a *Cronobacter*prevention strategy, enhanced inspection activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate. In March 2023, the FDA issued a letter to the powdered infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of infants. Additionally, in August 2023 the FDA issued three warning letters to infant formula manufacturers as part of the agencies enhanced oversight and to reinforce the importance of instituting and maintaining appropriate corrective actions when pathogens are detected and to comply with FDA’s laws and regulations.

Illegally imported formulas may be available online or from third-party distributors. These formulas are sometimes promoted as better for babies, but there is no scientific evidence that these infant formulas are better for babies than commercial infant formulas lawfully sold in the United States. All infant formulas legally sold in the United States—whether made in the United States or imported from other countries—must meet the same nutritional and safety requirements.

Parents feeding babies bottles of infant formula
Advice for Parents and Other Caregivers

While breastfeeding is strongly encouraged by the American Academy of Pediatrics, most infants in the U.S. rely on infant formula for some or all of their nutrition. The agency is working with manufacturers, who are now required to have risk redundancy plans, to ensure a stable and consistent supply of infant formula in the U.S., but we recognize that at times it may be difficult to find the formula you need. The Department of Health and Human Services has made resources available explaining what to do if you can’t find your formula.


**Products on the Market**

Check with your infant’s health care provider to determine which infant formula to choose.

Routine formulas are formulas intended for healthy, full-term infants. These formulas may contain cow’s milk, goat’s milk, or soy. These formulas can also be modified to meet specific needs of full-term infants who are not premature. For example:

Partially hydrolyzed infant formula contains cow’s milk proteins that have already been partially hydrolyzed, or broken down, and may be easier to digest.
	Spit-up formulas are thickened with the aim of reducing acid reflux.
	Lactose-free formula contains no lactose (a sugar found in milk) for infants that have difficulty digesting it.Specialty formulas are intended for use by an infant who has an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem. Some of these formulas are not available in retail settings and may be prescribed by a physician. Examples include:

Hypoallergenic formulas with extensively hydrolyzed protein that are effective for the treatment of milk protein allergy. In these formulas, the protein has been broken down so that it can be more easily digested.
	Formulas to treat a specific medical condition such as an inborn error of metabolism. For example, a formula for individuals with Phenylketonuria (PKU) does not contain the amino acid phenylalanine.
	Infant formulas for premature infants, which may include more nutrients and calories to meet their increased nutritional needs.
	Amino acid-based formulas, which contain amino acids as their protein source. These formulas can be used for infants with severe milk allergies, short-gut syndrome, or other medical conditions.Due to their composition and intended use to address specific conditions, specialty formulas may be exempt from certain nutrition labeling and nutrient specifications.

Infant formulas come in three forms:

Powder — Must be mixed with water before feeding.
	Liquid concentrate — Must be mixed with an equal amount of water before feeding.
	Ready-to-feed — Requires no mixing.The infant formulas currently available in the U.S. must be labeled as either “Infant Formula with Iron” or “Additional Iron May Be Necessary.” The American Academy of Pediatrics recommends that formula-fed infants receive an “Infant Formula with Iron” as a way of preventing iron-deficiency anemia.

Open can of infant formula with a scoop
Safe Preparation and Feeding of Formulas

*Cronobacter* is a germ (bacteria) that is naturally found in the environment and can contaminate powdered infant formula and cause illness. While infections are rare, they can be life-threatening in infants, particularly those who are younger than two months old, premature, immunocompromised, or of low birthweight. It is important for caregivers to know the risks and how to minimize them through safe handling, storage, and sanitation.


The safe preparation and feeding of formulas is important for your baby’s health. Prepare infant formula according to instructions on the infant formula label. The label also must include information on storing and throwing away prepared formula. Also, use safe handling techniques. For example, bottles, rings, caps, and nipples need to be cleaned and sanitized. Infant formula packages also must include the ***“Use By” Date***, which is the date up to which the manufacturer guarantees the nutrient content and the quality of the formula.

**Don’t Feed Infants Homemade Infant Formula**

The FDA advises parents and caregivers not to make or feed homemade infant formula to infants. Homemade infant formula recipes have not been evaluated by the FDA and may lack nutrients vital to an infant’s growth. The agency has received reports of hospitalized babies who have been fed homemade infant formula and then suffered from hypocalcemia (low calcium). Other potential problems with homemade formulas include contamination. These problems are serious, and the consequences may range from severe nutritional imbalances to foodborne illnesses, both of which can be life-threatening.

**Toddler Nutritive Drinks**

Toddler nutritive drinks, often marketed as “toddler formulas,” are not necessary to meet the nutritional needs of older babies. Babies younger than age 12 months should be fed infant formulas specifically designed to meet their nutritional needs. They should not be fed toddler drinks or formulas labeled for toddlers. Additionally, toddler nutritive drinks do not undergo premarket review by FDA.

Identifying and Reporting a Problem

If you have concerns about infant formula, contact your health care provider and FDA at 1-888-INFO-FDA (1-888-463-6332), or you can file a report online at MedWatch.


Information for Infant Formula Manufacturers

Manufacturers of infant formula must comply with applicable Federal Food, Drug, and Cosmetic Act requirements and those contained in FDA’s implementing regulations. More information on these requirements can be found on the FDA’s Infant Formula Guidance Documents & Regulatory Information webpage. In addition, the FDA has held a series of webinars (see Webinar Series to Discuss the Infant Formula Transition Plan for Exercise of Enforcement Discretion), for which recordings are now available, that discuss infant formula requirements.

A manufacturer who intends to market a new infant formula in the U.S. must register with, notify, and submit a written verification of regulatory compliance to the FDA. The FDA encourages infant formula manufacturers to contact infant_formula_flexibility@fda.hhs.gov with questions about infant formula. New infant formula submissions must be sent to the FDA at least 90 days before the introduction or delivery for introduction into interstate commerce of a new infant formula. In response to the infant formula supply disruption that followed the voluntary recall, the FDA has also taken multiple steps to improve the resiliency of the infant formula supply, including by providing manufacturers some flexibility through the exercise of enforcement discretion. You can learn more about this work through the agency’s Infant Formula Transition Plan for Exercise of Enforcement Discretion.

In 2022, safety concerns with powdered infant formula led to a voluntary recall of specific lots of powdered infant formula products manufactured at an Abbott Nutrition facility in Sturgis, Michigan. Since then, the agency has taken steps to enhance the safety of powdered infant formula through the development of a prevention strategy, enhanced inspection activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.

In March 2023, the FDA issued a letter to the powdered infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of infants. Among a number of items in the letter, the FDA asked that firms voluntarily notify the FDA any time a product sample is found to be positive for *Cronobacter spp.* Or *Salmonella*, even if the affected lot(s) have not been distributed. For these notifications of product positives, the FDA recommends that firms report this information through the ORA Division representative in which the manufacturing facility is located (see this ORA Field Leadership Contacts for further information). Continued communication through this established channel will help ensure that the information is received, acted on, and routed most appropriately in an efficient and timely manner.

As part of our enhanced oversight, the FDA also issued three warning letters to infant formula manufacturers in August 2023 to reinforce the importance of instituting and maintaining appropriate corrective actions when pathogens are detected and to comply with FDA’s laws and regulations. In addition, in September 2023 the FDA updated it’s infant formula compliance program to outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities related to the oversight of infant formula.

The Food and Drug Omnibus Reform Act of 2022 amended the Federal Food, Drug, and Cosmetic Act to add new requirements for manufacturers of critical foods, such as infant formula, including requirements:

to develop, maintain and implement risk redundancy plans to identify and manage risks to the supply of the critical food to help prevent future supply chain disruptions. The FDA recently developed a new resource for industry to help raise awareness and understanding of this new requirement.
	to notify FDA of meaningful disruptions in the production of formula that could lead to shortages.


Latest News

**Date**
			**Release**December 31, 2023
			Reckitt/Mead Johnson Nutrition Voluntarily Recalls Certain Nutramigen Hypoallergenic Powdered Infant Formula ProductsDecember 13, 2023
			FDA Provides Update on Actions to Strengthen the Safety and Supply Chain Resiliency of Infant FormulaOctober 6, 2023
			FDA Issues Updated Compliance Program for Infant FormulaSeptember 20, 2023
			FDA Provides Update on the *Cronobacter*Prevention StrategySeptember 14, 2023
			FDA Alerts Parents and Caregivers to Concerns Regarding LittleOak Infant FormulaMay 19, 2023
			FDA Announces National Academies Study of Supply, Market Competition, and Regulation of Infant Formula in the U.S.April 26, 2023
			FDA to Host Two Webinars on Infant Formula Food Ingredients and Packaging RequirementsMarch 28, 2023
			FDA Outlines Immediate National Strategy to Further Increase the Resiliency of the U.S. Infant Formula MarketFebruary 28, 2023
			FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs RestructuringFebruary 23, 2023
			What FDA’s Foods Program Achieved in 2022 to Protect Consumers and the Food SupplyJanuary 31, 2023
			FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response ActivitiesJanuary 9, 2023
			FDA Issues Letters of Acknowledgement for Infant Formula Transition PlanNovember 17, 2022
			Webinar Series to Discuss the Infant Formula Transition Plan for Exercise of Enforcement DiscretionNovember 16, 2022
			Focusing on Prevention to Safeguard Infant Formula

Food Safety & Nutrition from FDA

Handling Infant Formula Safely: What You Need to Know
	Questions & Answers for Consumers Concerning Infant Formula
	Do's and Don'ts with Infant Formula
	Help Prevent *Cronobacter* Illness: Prepare and Store Powdered Infant Formula Safely
	FDA Advises Parents and Caregivers to Not Make or Feed Homemade Infant Formula to Infants
	Food Safety Booklet for Pregnant Women, Their Unborn Babies, and Children Under Five
	Food Safety for Moms-To-Be - See Once Baby Arrives (Cuando llega el bebé)
	Foodborne Pathogens:*E. coli, Salmonella, Listeria, Cyclospora, Cronobacter sakazakii,* and Hepatitis A
	Food Safety for Infants & ToddlersImported Infant Formula and Infant Formula Supplies

Tips for Preparing Imported Infant Formula(Consejos para preparar la fórmula infantil importada)
	Find Formula During the Infant Formula Shortage (HHS)
	Enforcement Discretion for Infant Formula
	Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula MarketAlerts

FDA Advises Parents and Caregivers Not to Buy or Give Mother’s Touch Formula to Infants (2022)
	FDA Investigation of *Cronobacter* Infections: Powdered Infant Formula (2022)
	Additional Safety Advisories
	Outbreaks of Foodborne Illness
	Recalls, Market Withdrawals, & Safety AlertsResources from Other Agencies

Breastfeeding | NIH
	Children's Health | MEDLINEplus
	Women, Infants, and Children (WIC) | USDA - WIC provides Federal grants to States for supplemental foods, health care referrals, and nutrition education for low-income pregnant, breastfeeding, and non-breastfeeding postpartum women, and to infants and children up to age five who are found to be at nutritional risk.

                                                                                  Content current as of:
      01/10/2024
              
              
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