Handling Infant Formula Safely: What You Need to Know - FDA

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FDA Oversees Infant Formula Manufacturers

All manufacturers of infant formula sold in the United States (U.S.) must register with the U.S. Food and Drug Administration (FDA). Their products must meet the FDA’s nutritional quality and safety standards in order to be sold in the U.S.

Nutritional Requirements

Based on the nutritional needs of infants, FDA requires minimum amounts for 30 nutrients. FDA sets maximum amounts for 10 of those nutrients that can be harmful to an infant’s growth and development in high amounts, such as Vitamins A and D. Some infant formulas are made and labeled for infants that have certain medical conditions, such as metabolism issues, low birth weight, or an unusual medical or dietary problem. These specialized formulas do not have to meet these requirements.

Types of Infant Formula

Infant Formula Safety

Infant formula manufacturers must follow FDA’s Good Manufacturing Practices and other regulations to protect against harmful bacteria, viruses, chemicals, and other risks. If a company wants to sell a new formula or make changes to one that they already sell, they must submit the details to FDA.

The Dangers of Cronobacter

Cronobacter is a germ found everywhere around us. It can also live in water and in dry foods, such as:

• Powdered infant formula
• Powdered milk
• Herbal teas
• Starches, like flour or cornstarch

Cronobacter can cause rare but possibly deadly infections in infants, such as sepsis (a condition caused by a serious infection in the body) or meningitis (swelling of the protective membranes covering the brain and spinal cord, which can cause death or permanent disabilities).

Powdered infant formula may get contaminated with germs:

In the home: Cronobacter can get into powdered infant formula after the container is opened. Cronobacter can be found in other foods and live on surfaces like kitchen counters or sinks, and in water. Taking care to avoid cross contamination of bottles, nipples, and utensils during preparation is very important.

In a processing plant: If the manufacturer unintentionally uses ingredients that contain Cronobacter to make the formula, or if the formula powder touches a surface that has Cronobacter. Infant formula manufacturers must test every batch of infant formula for Cronobacter before release for sale.

Preparing and Handling Formula Safely

Preparing Formula - Always wash your hands with soap and water for at least 20 seconds before making formula for your baby.

Cleaning Bottles and Feeding Parts (including breastfeeding pump parts) - Before first use, boil bottles, nipples, caps, rings, and valves for 5 minutes. Afterward, following each use wash them in the dishwasher, if one is available, using hot water and a heated drying cycle (or sanitizing setting). If cleaning the feeding items by hand, wash them in soapy water in a basin used only for formula feeding parts, rinse, and air dry on a paper towel or clean dish towel.

Powdered Infant Formula Containers and Scoops - Powdered infant formula is unlikely to become contaminated if it stays dry. If you want to clean an unopened powdered infant formula container, use a disinfectant wipe or paper towel sprayed with disinfectant to clean the outside of the container and lid before it is opened for the first time. Don’t submerge the container or put it under running water. Don’t open the container until all surfaces are completely dry. Never clean the inside of the container. If the scoop falls into a sink, on a kitchen counter, or the floor, or is soiled some other way, clean it as you would the baby’s bottle. Let it air dry completely before using it.

Water - Always use water from a safe source to mix your infant formula. If you are not sure your tap water, whether from a public drinking water supply or private well, is safe to use for preparing infant formula, contact your local health department.

Bottled Water - Bottled water isn’t sterile (free of germs) unless the label says it is. If it is labeled as sterile and is specifically marketed for infants, it must meet FDA requirements for sterility in marketed products. If you use ordinary bottled water to make formula, handle it the same way as safe tap water.

Water Emergencies - If your water supply is cut off by a watermain break or polluted by a hurricane or flood, use bottled water to make formula instead of tap water. If you must use tap water that may be polluted, boil it for one minute (3 minutes at elevations above feet). to disinfect it and then let it cool in the pot for five minutes to room temperature before adding it to the bottle.

Mixing - Follow the instructions on the product’s label. Use the exact amount of water that the label says. Formula with too little water can cause dehydration (harmful loss of body fluid). Formula with too much water will not provide enough nutrition and, if fed to your baby for a long time, may result in slower growth. After adding the water, add the exact amount of formula called for on the label and shake to mix.

Storing - Use prepared infant formula within 2 hours. If it is not used immediately, store the bottle in the refrigerator and use it within 24 hours.

Formula Warming - Formula does not need to be warmed. If you prefer it warm, the best way is to place the bottle in a pot of water and heat it on the stove until warm (body temperature). Never use microwave ovens for heating infant formulas because microwaving can allow the bottle to remain cool while hot spots develop in the formula that can burn the baby’s mouth. Before feeding your baby, test the formula’s temperature by putting a few drops on your wrist. It should feel warm, not hot.

After Feeding - Throw away any leftover formula because it now contains the baby’s saliva, which can cause bacteria to grow.

Storing Opened Powdered Infant Formula - The package or container of infant formula must have information on how to store it before and after it is opened. It also must have information on when to throw away prepared formula. Follow the manufacturer’s directions on the label. Once a container of powdered formula is opened, the formula typically needs to be used within one month. Write the date that you opened the formula on the lid. With the lid tight, store in a cool dry place, not in the refrigerator.

“Use By” Date - Don’t use a package or container of infant formula after this date. The manufacturer guarantees the nutrient content and quality of the formula only up to the “use by” date. FDA rules require a “use by” date on every container of infant formula.

Freezing - Freezing is not recommended. It may cause the different parts of the formula to come apart and lower the quality.

Homemade Formula - The FDA advises caretakers to not make or feed their infant homemade infant formula. Homemade infant formula recipes have not been evaluated by the FDA and may lack nutrients vital to an infant’s growth.

Counterfeit (Fake) Formula - Formula products are sometimes taken from normal distribution channels and relabeled to fake the quality or identity of the product. Examples include changing the “use by” date or relabeling the product to hide the true content. This is illegal and can lead to serious health conditions for infants. A wide selection of infant formula is available on the market. If parents have questions about selecting a formula for their infant, they should ask their infant’s healthcare provider.

Formula Changes - Check for any changes in formula color, smell, or taste. If you buy formula by the case, make sure the lot numbers and “use by” dates on the containers and boxes match. Also, check containers for damage, and call the manufacturer’s toll-free number with any concerns or questions. You can also contact FDA at 1-888-SAFEFOOD (1-888-723-).

Additional Information 

• Infant Formula
• Food Safety for Infants & Toddlers
• Safe Feeding of Babies at Higher Risk of Foodborne Illness (Consumer Infographic)
• Tips for Safely Preparing Powdered Infant Formula (Consumer Infographic)
• Tips for Preparing Imported Infant Formula (Consumer Infographic)
• Help Prevent Cronobacter Illness: Prepare and Store Powdered Infant Formula Safely (Consumer Infographic)
• Information for Health Care Professionals on Safe Handling of Infant Formula

Translations 

en español (Spanish) 

• La fórmula infantil
• Manipulación segura de la leche de fórmula infantil: Lo que necesita saber
• Alimentación segura de bebés con mayor riesgo de enfermedades transmitidas por los alimentos
• Consejos para preparar la leche de fórmula infantil en polvo de forma segura
• Consejos para preparar la fórmula infantil importada
• Información para profesionales de la salud sobre la manipulación segura de la leche de fórmula infantil

العربية (Arabic)

• كيفية التعامل مع حليب الأطفال بأمان
• لرضاعة الآمنة للأطفال الأكثر عرضةللإصابة بالأمراض المنقولة بالغذاء
• نصائح لتحضير حليب الأطفالالمجفف بأمان

မြန်မာ (Burmese)

• အစားအစာ အချက်အလက်များ 
• အစာကြောင့်ဖြစ်သော ရောဂါဖြစ်နိုင်ခြေ မြင့်မားသော ကလေးငယ်များအား ဘေးကင်းစွာ ကျွေးမွေးခြင်း
• ကလေးဖော်မြူလာနို့မှုန့်ကို ဘေးကင်းစွာ ဖျော်စပ်ပြင်ဆင်ခြင်းအတွက် အကြံပြုချက်များ

دری (Dari)

• استفاده مصئون از شیرخشک طفل نوزاد
• تغذیه مصئون اطفال نوزادی که در معرض خطر بلندتر امراض ناشی از غذا هستند
• نکاتی برای آماده کردن مصئونشیرخشک پودری طفل نوزاد

नेपाली (Nepali) 

• शिशुको फर्मुला सुरक्षित रूपमा ह्यान्डल गर्दै: के तपाईंले जान्न आवश्यक छ 
• खाद्यजन्य रोगको उच्च जोखिममा रहेका बच्चाहरूलाई सुरक्षित खाना खुवाउनुहोस्
• सुरक्षित रूपमा तयारीका लागि सुझावहरू पाउडर गरिएको शिशु फर्मुला

Soomaali (Somali) 

Wondering about the correct formula-to-water ratio? How about whether it’s okay to reheat formula? Whether you’re looking for answers to questions about proper storage of baby formula or mixing tips and tricks, we’re here to help!

In this guide, we’re answering questions, providing important safety information, and giving step-by-step instructions on how to prepare your baby’s formula. Following these instructions will save you time and help you keep your formula-fed baby happy and healthy.

Skip to - Before you start: choosing a formula
Skip to - How to prepare Similac® powder formula
Skip to - Similac ready-to-feed formula instructions
Skip to - How to warm a bottle
Skip to - Have questions? Don’t keep them bottled up!

Before you start: choosing a formula

Choosing the right formula will largely depend on the guidance of your baby’s pediatrician and your baby’s individual needs. Baby formulas are not “one-size-fits-all.” What’s best for one baby may not be best for yours! The right formula will be one that is easy for your baby to digest and supports their nutrition needs.

If you are looking for more details, kindly visit milk powder mixing machine.

Check out our Formula Guide to learn more about the different Similac formula options. If you’re not sure which formula is best for your baby, ask your baby’s doctor. In addition, our Formula Finder can provide suggestions based on your baby’s needs!

Baby bottles: what kind should I use? 

You can use any bottle that your baby prefers or is recommended by your baby's pediatrician. For more advice on bottles and nipples, take a look at our Bottle Guide.

How to prepare Similac® powder formula

Follow these simple steps to help protect your baby’s health and make sure they receive the nutrition they need. You can always refer to the specific preparation instructions that are printed on the side of your formula container.

Note: Before prepping your formula, remember to always check the date on your formula container. Never feed your baby expired formula or formula from a dented container.

Supplementing breast milk with formula may be an option that supports your feeding goals. While you can alternate between breast milk and formula, it’s also okay to mix breast milk with prepared formula.

See our article for more information on introducing formula to your breastfeeding baby. 

What temperature should baby formula be?

Baby formula can be served cold, room temperature, or warmed.

If you do choose to warm your formula, it’s important to do it safely. See how to properly warm a bottle below.

How much should I feed my baby?

Your baby will need different amounts of formula at different stages in their development. Babies also give certain cues to tell you when they’re full! To learn more about how much formula your baby needs, see our article on formula feeding.

Similac ready-to-feed formula instructions

Ready-to-feed formula is what it sounds like—ready to go when you need it! It’s a great option to make nighttime feeding or feeding while traveling more convenient.

There's no mixing required and only minimal prep work. Simply wash your hands, shake the ready-to-feed bottle before opening, and pour the formula into a clean baby bottle. Or, if you’re using a 2-fl-oz or 8-fl-oz ready-to-feed bottle, just twist on the nipple and ring. It’s that easy!

Note: If your baby doesn't finish a bottle of formula within 1 hour, throw it away.

How to store unopened ready-to-feed bottles

Store unopened ready-to-feed formula at room temperature; avoid extreme temperatures and protect from light. Store in original packaging until ready to use.

Storing ready-to-feed formula once opened

Storage of opened ready-to-feed formula will depend on which formula you are using.

• 32-fl-oz bottles: Immediately store re-capped, opened 32-fl-oz bottle in the refrigerator. Use the remainder of the formula within 72 hours of opening. If you pour the 32-fl-oz bottle into individual baby bottles, refrigerate them, and use within 48 hours.

• Alimentum® 32-fl-oz and 8-fl-oz: Store capped, opened container immediately in the refrigerator and feed within 48 hours. If using Alimentum 8-fl-oz ready-to-feed can, cover opened container and store immediately in the refrigerator. Feed within 48 hours.

• 2-fl-oz and 8-fl-oz nipple-ready bottles: Cover and store immediately in the refrigerator. Feed within 48 hours, unless otherwise stated on the label or carton.

Do not reuse ready-to-feed bottles. Protect opened bottles from light.

How to warm a bottle

Baby formula doesn’t need to be warmed, but if you prefer to warm it, do not microwave it. Microwaving baby formula can cause “hot spots” that can burn your baby. Instead, try one of the following methods.

Appropriate ways to warm formula

Water bath. Set the filled and capped bottle in a bowl of warm (not boiling) water. Make sure the top or neck of the bottle does not touch the water. Before feeding, swirl or shake the bottle to distribute warmed formula evenly, then sprinkle a few drops of formula on the inside of your wrist to make sure it’s not too hot.

Warm running water. Hold the capped bottle under warm running tap water. Make sure the top or neck of the bottle does not touch the water. Before feeding, swirl or shake the bottle to distribute warmed formula evenly, then sprinkle a few drops of formula on the inside of your wrist to make sure it’s not too hot.

Can you reheat formula?

Unfortunately, no. Once formula has been prepared and warmed, it’s best to serve it to your baby right away. Feeding reheated formula can negatively impact your little one’s health, as reheating can increase the potential for bacteria to breed and increase the risk of foodborne illness. Once feeding begins, use within 1 hour.

Have questions? Don’t keep them bottled up!

Find answers to some of your frequently asked questions below.

How much should I be feeding?

Your baby will need different amounts of formula at different stages in their development. Babies also give certain cues to tell you when they’re full! To learn more about how much formula your baby needs, see our article on formula feeding.

After opening a container of ready-to-feed formula, how long can it sit out?

If not being fed to your baby, formula should be immediately stored in the refrigerator until your baby’s next feeding.

Can I store Similac powder formula in a different container than the original can?

We recommend keeping Similac powder formulas in their original containers. Our packaging containers are specifically designed for infant formula. They are made up of several layers that include barriers to oxygen and light, which can break down light-sensitive vitamins in our formula. A clear container or jar would not have these special layers.

Please note that each Similac container may have a different batch number and expiration date; this is another reason to keep powder in the original container.

Can I make a large batch of powder formula, or should I make individual bottles?

Yes, you can save yourself time by making multiple bottles of formula at once! If you are preparing a larger amount, just make sure to only prepare what your baby would drink in a 24-hour period. Then pour the prepared formula into individual feeding bottles, cap and store them immediately in the refrigerator, and use within 24 hours.

How can I prevent my formula from getting clumpy?

Clumps can form in your formula if the water and powder don’t get thoroughly mixed. It is important to measure the water carefully and add it to the mixing container or bottle first, then add the powder.

My baby doesn’t seem to like the formula I’m giving them.

If your baby isn't responding well to the formula you’re using, consult your baby's pediatrician. It’s possible that it’s not the right formula for them. Try our Formula Finder and our Tummy Trouble Tool for customized suggestions on how to help your little one feel better. It’s also possible that your baby isn’t liking the bottle or nipple you’re using. Take a look at our Similac bottles and nipples for new options.

How long does powder formula last once prepared?

Once mixed or refrigerated, baby formula must be used within 24 hours.

How far in advance can you make baby formula?

You can make baby formula up to 24 hours in advance. See the above instructions on how to prepare a batch of formula for more information.

Can you make baby formula with distilled water?

Yes, you can use distilled water to make formula. Tap water is normally safe, but if the water becomes unsafe in an emergency, such as a flood or a hurricane, you can use either distilled or purified water. Ask your baby’s pediatrician for the safest option for your baby.

Can I make my own homemade baby formula?

We do not recommend using a homemade baby formula. Using homemade baby formula can lead to serious health problems for your baby. Your baby’s nutrition needs are very specific, especially in their first year of life, and homemade formulas may contain too little or too much of certain components, such as vitamins and minerals (like iron). They may also have an increased risk of contamination, which could make your baby sick.

How can I save money on Similac formula and get other feeding support?

To save money on formula and more, sign up to join MySimilac® Rewards.

Have questions we didn’t cover? Consider getting live support from our Feeding Expert team by calling 800-986- (8:30 AM – 7 PM ET) or talk to your doctor for more information. 

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