Is My Infant Formula Safe?

In March 2025, a consumer report revealed some infant formulas contained harmful chemicals like arsenic, lead, and BPA. For parents, this adds stress to an already difficult and costly decision of choosing a formula for their baby.

The Food and Drug Administration (FDA) makes sure that infant formula is safe for babies by following the Infant Formula Act of 1980. They make sure that formula has the right nutrients for your baby and does not have harmful bacteria. This consumer report has urged the FDA to strengthen safety measures.

What Did the Report Find?

• About half of the 41 different formulas tested had at least one of the harmful contaminants in them. The other half showed low or no detectable levels, proving safer options exist.
• Mercury: None of the formulas had mercury.
• Arsenic: Arsenic can be dangerous in large amounts. It can be found in the environment, water, and even in human milk. All the formulas tested had very low levels of arsenic, under the safety limit based on European Union (EU) standards.
• Lead: Lead can be found in food, water, and even dust. It is very hard to remove all lead from formulas. Eighteen formulas had lead, but all were still below the safety limit based on FDA and EU standards.
• BPA: BPA is a chemical that used to be in many products, but it is less common now. Only one formula had BPA in it.
• It is important to know that all of the formulas were still safe to use, and all met the standards set by the FDA and EU.
• The FDA does not have set safety standards for all these contaminants like the EU. However, EU guidance tends to be either equivalent to FDA standards or even stricter.

How Do Contaminants Get in Infant Formulas?

Infant formula can contain trace amounts of lead, mercury, and arsenic from environmental and manufacturing sources—also found in food, water, and human milk. While they cannot be fully eliminated, the FDA’s “Closer to Zero” initiative aims to reduce them, especially for babies and young children.

What Is the FDA’s Response to the Consumer Report?

After the report, the FDA quickly responded with actionable steps. Their new program “Operation Stork Speed” increases formula oversight, testing, and safety regulations to make infant formula even safer. The goals of this program include:

• Updating and reviewing the nutrients in infant formula for the first time since 1998
• Increasing testing of formulas for harmful chemicals
• Encouraging formula companies to work with the FDA to be more transparent on nutrient labels
• Working with other health organizations, such as National Institutes of Health (NIH) to research short- and long-term health outcomes associated with formula feeding in infancy and childhood across the lifespan

What Should Parents Know?

The FDA and other health groups are working to improve formula safety, including updating regulations. Environmental regulations play a key role in keeping levels of contaminants lower.

Though some formulas contained small amounts of contaminants, all were within FDA and EU safety limits. These substances also appear in other foods, water, and even human milk. Formula companies have reported that appropriate testing measures are always taken and meet current regulatory standards.

You can minimize your baby’s risk of harmful contaminate exposure by mixing infant formula with a clean water supply. Some babies may require specialty formulas for certain medical conditions to achieve growth and development. If you have concerns or preferences, you should talk to your pediatrician or dietitian before changing formulas to discuss potential alternative options.

US infant formula is safe. If human milk is unavailable, infant formula is the safest option. We do NOT recommend making infant formula at home. It is important to talk with credible sources such as a pediatrician or dietitian to tease out misinformation.