thumb|Infant formula|250x250px

thumb|Cans of formula (brand name Nidina) as sold in Argentina

Infant formula, also called baby formula, simply formula (American English), formula milk, baby milk, or infant milk (British English), is a manufactured food designed and marketed for feeding infants under 12 months of age, usually prepared for bottle-feeding or cup-feeding from powder (mixed with water) or liquid (with or without additional water). The U.S. Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "a food which purports to be or is represented for special dietary use solely as a food for infants because it simulates human milk or its suitability as a complete or partial substitute for human milk".

The use of infant formula has been found to be associated with health risks such as type 1 and 2 diabetes, sudden infant death syndrome (SIDS), eczema, and more when compared to infants who are breastfed.

A 2001 World Health Organization (WHO) report found that infant formula prepared per applicable Codex Alimentarius standards was a safe complementary food and a suitable breast milk substitute. In 2003, the WHO and UNICEF published their Global Strategy for Infant and Young Child Feeding, which restated that "processed-food products for ... young children should, when sold or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission", and also warned that "lack of breastfeeding—and especially lack of exclusive breastfeeding during the first half-year of life—are important risk factors for infant and childhood morbidity and mortality". Despite the recommendation that babies be exclusively breastfed for the first 6 months, 48% of infants below this age are exclusively breastfed worldwide. The overwhelming majority of American babies are not exclusively breastfed for this period—in 2025 24.9% of babies were breastfed exclusively for the first 6 months, with nearly 40% of babies less than 3 months of age being supplemented with infant formula in 2022, and approximately 20% of infants having infant formula feeding within two days of birth. The use of hydrolysed cow milk baby formula versus standard milk baby formula does not appear to change the risk of allergies or autoimmune diseases.

Use of infant formula

In some cases, breastfeeding is medically contraindicated; these include:

  • Mother's health: The mother is infected with HIV or has active tuberculosis. She is extremely ill or has had certain kinds of breast surgery, which may have removed or disconnected all milk-producing parts of the breast. She is taking any kind of drug that could harm the baby, including both prescription drugs such as cytotoxic chemotherapy for cancer treatments, as well as illicit drugs. However, if a mother has HIV, she is more likely to transmit it to her child during the pregnancy or birth than during breastfeeding. A 2012 study conducted by researchers from the University of North Carolina School of Medicine showed reduced HIV-1 transmission in humanized mice, due to components in the breast milk. Cytomegalovirus infection poses potentially dangerous consequences for pre-term babies. Other risks include mother's infection with HTLV-1 or HTLV-2 (viruses that could cause T-cell leukemia in the baby),
  • In balancing the risks, such as cases where the mother is infected with HIV, a decision to use infant formula versus exclusive breastfeeding may be made based on alternatives that satisfy the "AFASS" (Acceptable, Feasible, Affordable, Sustainable and Safe) principles.
  • Baby is unable to breastfeed: The child has a birth defect or inborn error of metabolism such as galactosemia that makes breastfeeding difficult or impossible.
  • Baby is considered at risk for malnutrition: In certain circumstances infants may be at risk for malnutrition, such as due to iron deficiency, vitamin deficiencies (e.g. vitamin D which may be less present in breast milk than needed at high latitudes where there is less sun exposure), or inadequate nutrition during transition to solid foods. Risks can often be mitigated with improved diet and education of mothers and caregivers, including availability of macro and micronutrients. For example, in Canada, marketed infant formulas are fortified with vitamin D, but Health Canada also recommends breastfed infants receive extra vitamin D in the form of a supplement.

Other reasons for not breastfeeding include:

  • Personal preferences, beliefs, and experiences: The mother may dislike breast-feeding or find it inconvenient. In addition, breastfeeding can be difficult for victims of rape or sexual abuse; for example, it may be a trigger for posttraumatic stress disorder. Many families bottle feed to increase the father's role in parenting his child.
  • Mental health: The pressure to breastfeed in many cultures can be so much that the mother's mental health may take a sharp decline. This can have physical effects such as poor latching, as well as milk depletion and a lack of connection to the child. In some cases, the child should be formula-fed so that a better bond can be made between mother and child, rather than the 'special bond' that comes from breastfeeding being tainted by negative breastfeeding experiences. The pressure to breastfeed in many cultures can increase the likelihood of postpartum depression.
  • Absence of the mother: The child is adopted, orphaned, abandoned, or in the sole custody of a man or male same-sex couple. The mother is separated from her child by being in prison or a mental hospital. The mother has left the child in the care of another person for an extended period of time, such as while traveling or working abroad.
  • Food allergies: The mother eats foods that may provoke an allergic reaction in the infant.
  • Financial pressures: Maternity leave is unpaid, insufficient, or lacking. The mother's employment interferes with breastfeeding. Mothers who breastfeed may experience a loss of earning power.
  • Societal structure: Breastfeeding may be forbidden, discouraged, or difficult at the mother's job, school, place of worship, or in other public places, or the mother may feel that breastfeeding in these places or around other people is immodest, unsanitary, or inappropriate. Conversely, societal pressures to breastfeed can also lead to mental health issues. A sense of shame from not being able to or struggling to do so equalling being a failure, has a connection to Postpartum Depression
  • Lactation insufficiency: The mother is unable to produce sufficient milk. In studies that do not account for lactation failure with obvious causes (such as use of formula and/or breast pumps), chronic lactation insufficiency affects around 10–15% of women. For about 5–8% of women, milk coming in (i.e., lactogenesis II) may not occur at all, and only drops are produced. Alternatively, despite a healthy supply, the woman or her family may incorrectly believe that her breast milk is of low quality or in low supply. These women may choose infant formula either exclusively or as a supplement to breastfeeding. New research is showing that mothers who report problems with milk production have physical markers indicating low milk production, calling into question the assumption (called "perceived insufficient milk supply" or PIMS) that mothers are incorrect about the quantity of milk they are producing.
  • Fear of exposure to environmental contaminants: Certain environmental pollutants, such as polychlorinated biphenyls, can bioaccumulate in the food chain and may be found in humans, including mothers' breast milk.
  • However, studies have shown that the greatest risk period for adverse effects from environmental exposures is prenatally.
  • Research on risks from chemical pollution is generally inconclusive in terms of outweighing the benefits of breastfeeding.
  • In developing countries, environmental contaminants associated with increased health risks from use of infant formula, particularly diarrhoea due to unclean water and lack of sterile conditions – both prerequisites to the safe use of formula – often outweigh any risks from breastfeeding.
  • Lack of other sources of breast milk:
  • Lack of wet nurses: Wet nursing is illegal and stigmatized in some countries, and may not be available. It may also be socially unsupported, expensive, or health screening of wet nurses may not be available. The mother, her doctor, or family may not know that wet nursing is possible, or may believe that nursing by a relative or paid wet-nurse is unhygienic.
  • Lack of milk banks: Human-milk banks may not be available, as few exist, and many countries cannot provide the necessary screening for diseases and refrigeration.

Health risks and controversies

The use of infant formula has been cited for association with numerous increased health risks. Studies have found infants in developed countries who consume formula are at increased risk for acute otitis media, gastroenteritis, severe lower respiratory tract infections, atopic dermatitis, asthma, obesity, type 1 and 2 diabetes, sudden infant death syndrome (SIDS), eczema and necrotizing enterocolitis when compared to infants who are breastfed. Some studies have found an association between infant formula and lower cognitive development, including iron supplementation in baby formula being linked to lowered I.Q. and other neurodevelopmental delays; however other studies have found no correlation.

Melamine contamination

In 2008, a case of melamine poisoning of infant formula was discovered in China, where milk was deliberately adulterated with the chemical, leading to the death of six babies, and illnesses in more than 300,000 infants, including cases of acute kidney failure. Large quantities of melamine were added to watered-down milk to give it the appearance of having adequate protein levels. Some of those responsible for the poisoning were sentenced to death. — Abbott Laboratories, Nestlé, and Mead Johnson — responsible for 90–99% of the infant formula market in the country. although concerns remain about the safety of manufactured food for infants and monitoring of potentially dangerous substances.

Bacterial Contamination

Like many prepared food products, infant formulas are occasionally contaminated with disease causing bacteria, occasionally at the source of production. Cronobacter sakazakii (formerly Enterobacter sakazakii), is a Gram-negative bacterium that has been occasionally found in infant formula products, likely due to its association with dried foods. Rarely, use of powdered infant formula (PIF) has been associated with serious illness, and even death, due to infection with Cronobacter sakazakii and other microorganisms that can be introduced to PIF during its production. Although C. sakazakii can cause illness in all age groups, infants are believed to be at greatest risk of infection. Between 1958 and 2006, there have been several dozen reported cases of C. sakazakii infection worldwide. The WHO believes that such infections are under-reported. In November 2025, infant formula contaminated with spores of the bacteria Clostridium botulinum, the causative agent of botulism, were detected as the cause of an outbreak of infant botulism sickening 13.

In January 2026, Nestlé issued a global recall of some batches of infant formula, due to the presence of cereulide, a heat-stable toxin produced by some strains of Bacillus cereus, B. megaterium and related species. The cereulide was found in a Nestlé production facility in the Netherlands. Danone also recalled a single batch of infant formula. The contaminated ingredient was arachidonic acid oil from Chinese supplier Cabio Biotech.

Other health controversies

  • In 1985, Syntex Corporation was ordered to pay $27 million in compensation for the deaths of two American infants who suffered brain damage after drinking the company's baby formula, called Neo-mull-soy. Formulas produced by Syntex had previously been subject to a major recall as they were found to have insufficient chloride to support normal infant growth and development.
  • In 2003, baby plant-based formula manufactured by the German company Humana and sold in Israel under the brand Remedia caused severe vitamin deficiencies in babies. Babies who consumed the formula were hospitalized with cardiac and neurological symptoms. Three of them died, and at least twenty others were left with severe disabilities. An investigation revealed that the formula contained a much lower quantity of Thiamine than is needed for healthy infant development because of a manufacturing error. Humana's chief food technologist received a 30-month prison sentence for negligent manslaughter in February 2013 over the case.
  • In 2010, Abbott Laboratories issued a voluntary recall of about five million Similac brand powder infant formulas that were sold in the United States, Guam, Puerto Rico, and some Caribbean countries. The recall was issued after the presence of a 'small common beetle' was detected in the product.
  • In Canada, New Zealand, and elsewhere, public concerns have been raised over the continued sale and marketing of soy-based formulae potentially containing high levels of phytoestrogens, linked to abnormal child development including damage to babies' thyroid glands.
  • In December 2011, Wal-Mart recalled a quantity of infant formula after a baby died in Missouri. "We extend our deepest condolences to this baby boy's family as they try to come to grips with their loss," said Dianna Gee, a Wal-Mart spokeswoman. "As soon as we heard what happened, we immediately reached out to the manufacturer of the formula and to the Department of Health and Senior Services to provide any information we may have to help with the investigation." Wal-Mart said it pulled a batch of Enfamil from its stores nationwide that matched the size and lot number ZP1k7G of the formula that may have sickened the baby in Missouri, Gee said. The baby formula was purchased from a Walmart in Lebanon, Missouri. After the purchase, a 10-day-old infant died from a rare bacterial infection, CNN affiliate KYTV reported. Authorities ran tests to determine if the death came from the formula, the water to make the formula, or any other factor, said Mead Johnson Nutrition, the company that makes Enfamil. "We are highly confident in the safety and quality of our products – and the rigorous testing we put them through," said Chris Perille, a Mead Johnson Nutrition spokesman.

Socioeconomic conditions

According to a research conducted in Vancouver, Canada, 82.9% of mothers breastfeed their babies at birth, but the number differed between white mothers (91.6%) and non-white mothers (56.8%), with the difference essentially attributed to marital status, education and family income. In the United States, mothers of lower socio-economic status are less likely to breastfeed, although this may be partly related to the adverse effects of government nutrition supplementation programs that provide subsidies for infant formula. A formula-fed child living in unclean conditions is between 6 and 25 times more likely to die of diarrhea and four times more likely to die of pneumonia than a breastfed child.

Preparation and content

Variations

Infant formulas come in powder, liquid concentrate, and ready-to-feed forms. They are designed to be prepared by the parent or caregiver in small batches and fed to the infant, usually with either a cup or a baby bottle.

Manufacturers and health officials advise that it is very important to measure powders or concentrates accurately to achieve the intended final product concentration; otherwise, the child will be malnourished. All equipment that comes into contact with the infant formula should be cleaned and sterilized before each use. Proper refrigeration is essential for any infant formula that is prepared in advance.

In developing countries, formula is frequently prepared improperly, resulting in high infant mortality due to malnutrition and diseases such as diarrhea and pneumonia. This is due to a lack of clean water, lack of sterile conditions, a lack of refrigeration, illiteracy (so written instructions cannot be followed), poverty (diluting formula so that it lasts longer), and a lack of education of mothers by formula distributors. These problems and resulting disease and death are a key factor in opposition to the marketing and distribution of infant formula in developing countries by numerous public health agencies and NGOs (discussed in more detail at Nestlé boycott and International Code of Marketing of Breast-milk Substitutes).

Nutritional content

Manufacturers state that the composition of infant formula is designed to be roughly based on a human mother's milk at approximately one to three months postpartum; however, there are significant differences in the nutrient content of these products. The most commonly used infant formulas contain purified cow's milk whey and casein as a protein source, a blend of vegetable oils as a fat source,