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Enfamil® Formula Safety

Enfamil® Formula Safety and Availability

There was a recall of select infant formulas made by another manufacturer that has impacted the supply of infant formulas across the nation, but be reassured that no Enfamil products are affected. We are taking no chances to ensure the continued safety and quality of all Enfamil products.

Aug 24, 2022

Enfamil receives approval to import specialty base formula, PurAmino for infants and toddlers who cannot digest other types of formula due to food allergies or other conditions requiring an elemental diet.

On August 11, 2022, we received approval from the United States Food and Drug Administration (FDA) to import more than 33,000 pounds of infant formula base powder from a Reckitt nutrition facility in Delicias, Mexico. The base powder will be blended and packaged in the United States and provide approximately 6 million 8-oz servings of PurAmino, a specialty formula for infants and toddlers who cannot digest other types of formula due to food allergies or other conditions requiring an elemental diet.

Our state-of-the-art facility in Delicias, Mexico has already been exporting to 15 countries and will now be delivering PurAmino base to our facility in Zeeland, Michigan, where it will be blended, packaged, and distributed throughout the United States.

The PurAmino formula brand will primarily be distributed through hospitals and healthcare providers in order to best reach those with critical medical needs. At the same time, PurAmino may be found on shelves alongside other Enfamil brands that we’ve been replenishing, to retailers and stores near you.

To date, we have successfully brought in hundreds of thousands of pounds of infant formula base powder from our other state-of-the-art facilities in Singapore, and plan to continue ramping up production to provide as much infant formula as possible without compromising safety or quality of the product.

Aug 10, 2022

Competitor Recall Response: Enfamil Redoubles Efforts to Restock Shelves with Infant Formula

We are proud to announce that more infant formula is on its way to stores near you. Working closely with the White House and other government agencies, we successfully brought a substantial shipment to America as part of Operation Fly Formula which delivered more 423,000lbs of infant formula base powder in July from our Tuas, Singapore facility. The base powder has been blended, packaged, and is on its way to store shelves across the U.S.

Since the July shipment we’ve continued scaling up our operation and plan to deliver more than 770,000 pounds of infant formula base powder to the US from our Tuas, Singapore facility in August, to be blended, packaged, and distributed in the United States.

Each month through September of 2022 we expect to increase delivery by self-funding flights from our international facilities to the United States. This initiative comes with the expansion of our Fight for Access Fund, which is dedicated to expanding access to quality hygiene, health, and nutrition worldwide.

We are proud to provide for babies across the United States by feeding more than 50% of all infants with our Enfamil brand, which is the number one trusted brand by pediatricians and parents.

Jun 22, 2022

We are Taking Extraordinary Steps to Increase Access to Infant Formula

In light of the continuing shortage of infant formula in the United States, Mead Johnson provided an update on its ongoing efforts to ensure that more formula reaches store shelves and the parents who need it. Mead Johnson received confirmation of import approval on June 15, 2022 by way of an enforcement discretion letter from the United States Food and Drug Administration (FDA) to import the equivalent of 66 million 8-oz servings of base infant formula powder from Reckitt’s Tuas, Singapore, facility between now and November.

Reckitt will work closely with the Administration and Operation Fly Formula to ensure formula reaches families as quickly as possible. This additional supply would represent the biggest contribution yet from any manufacturer in solving the continuing infant formula shortage in the United States.

This announcement will enable Reckitt to complete the final stage of product readiness for the U.S. market and we will:

  • Provide 190 metric tons of infant formula base powder from our Tuas facility in Singapore which will be blended and packaged in the U.S. This would be the equivalent of 5.9 million 8-oz servings, which we anticipate will be available in the coming weeks.
  • Prioritize channels that are available to parents who qualify for the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and are among the most vulnerable in this shortage.
  • Supply 500 metric tons per month by October through the Tuas facility. This would be the equivalent of 15.5 million 8-oz servings.

To date, our ongoing efforts to increase access to infant formula include:

  • Operating our plants 24/7.
  • Streamlining our product portfolio to maximize production capacity.
  • Working with the United States government on securing additional manufacturing inputs and unlocking further capacity from our Delicias, Mexico facility.
  • Partnering with retailers to expedite orders and trucks and prioritizing formula at their distribution centers to fill shelves more quickly.
  • Dispatching product as soon as we have verified the quality and safety needed to meet the high standard for the sole source of nutrition.
  • Feeding an additional 211,000 more babies than before the shortage.

According to President of Reckitt’s Nutrition Business Pat Sly “Over the past three months we have been doing everything possible to put more formula on shelves, addressing the concerns of parents across the country. We are leaving no stone unturned to increase our supply, while safeguarding the highest levels of quality.”

As a result, we shipped over 30% more infant formula in Q1 vs 2021, cut time to shelf by 40% without sacrificing quality and are currently feeding 211,000 more babies than we were prior to the shortage. We are also identifying other ways to ensure parents and infants have a steady supply of safe, high-quality formula. These include pursuing the Food and Drug Administration’s (FDA) import exception, which would permit us to import additional infant formula supplies into the United States from our manufacturing facility in Mexico. Should we receive regulatory approval, we would be able to provide approximately 170 metric tons of infant formula per month on average from our Delicias, Mexico facility.

Our Commitment to Quality: Enfamil Products Remain Safe

The health and safety of our consumers is our top priority. All Enfamil, Nutramigen and PurAmino branded products are safe to use and remain available.

All of our infant formulas have undergone extensive quality tests and checks, which meet or exceed all standards set by the U.S. FDA. We wish to remind caregivers that the health of their baby depends on carefully following all label instructions regarding safe preparation and usage.

If you have any questions or concerns about using our products or trying one for the first time, please don’t hesitate to contact us.

Call us at 1-800-BABY123.

Helping You Find Alternative Formulas

We understand that the supply situation is worrisome to parents and understand how important infant formula is for babies and children who rely on it. If needed, we can help you according to your necessity.

Replenishing Supply

We are continuing to increase production of Enfamil products to help restock the shelves and make more formula readily available to more babies. We will continue to work closely with retailers and suppliers to keep our store locator up-to-date to help you find Enfamil formula products near you.

How to Find Formulas Online

When searching for infant formula online, be sure to update the default search filters. Check off curbside or delivery options, as these may cause the website to incorrectly say that there is no formula available or in stock, and there may actually be some available for in-store purchase. Always call ahead to confirm availability.

Where to Look for Formula Samples

Some pediatricians and hospitals have samples available for parents in need. Your pediatrician can also provide the best guidance for which formula alternatives and/or Enfamil product(s) would best suit your baby’s needs.

Which Enfamil Formula is right for my baby?

Your pediatrician is the best person to ask about your baby’s individual needs, and if you know what ingredients to look for, visit our formula comparison page to see how Enfamil products compare to other brand formulas you may have used.

Need to reach us? Call us!

We are prioritizing our responses to those with urgent questions and needs. The best way to reach us right now is to call 1-800-BABY123.



Updated 08/15/22 08:55 AM EST

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