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FoodRecallWatch
Regulation & Compliance

Adulteration

When a food product contains an unsafe substance, was processed under unsanitary conditions, or otherwise violates FDA safety standards.

What It Means

Adulteration in the context of food safety refers to a food product that is deemed unsafe or substandard under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 402 of the FD&C Act defines food as adulterated if it bears or contains any poisonous or deleterious substance that may render it injurious to health; if it contains any added poisonous or deleterious substance that is unsafe; if it consists in whole or in part of any filthy, putrid, or decomposed substance; if it has been prepared, packed, or held under insanitary conditions where it may have become contaminated; if it contains an unsafe food additive or color additive; or if it contains a new animal drug that is unsafe. Adulteration is one of the primary legal bases for FDA food recalls. A food does not need to have actually caused illness to be considered adulterated, the mere potential for harm or the presence of unsanitary conditions is sufficient. Economic adulteration, where a cheaper substitute is used to cut a more expensive ingredient (such as diluting honey with corn syrup or substituting lower-quality fish species), is also a form of adulteration. The FDA addresses adulteration through inspections, sampling, testing, warning letters, recalls, import alerts, and in serious cases, criminal prosecution.

Related Terms

Frequently Asked Questions

What does Adulteration mean?

When a food product contains an unsafe substance, was processed under unsanitary conditions, or otherwise violates FDA safety standards.

Why is Adulteration important for food safety?

Adulteration in the context of food safety refers to a food product that is deemed unsafe or substandard under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 402 of the FD&C Act defines food as adulterated if it bears or contains any poisonous or deleterious substance that may render i...

this entity is one of the U.S. FDA food, drug, and device recalls concepts that recurs across this site. The definition above is the technical answer; the paragraphs below add the practical context for how the concept connects to the the FDA openFDA enforcement-report API data behind every per-entity page on the site.

In the the FDA openFDA enforcement-report API data, this concept shapes one or more of the fields that drive the per-entity grades and rankings on this site. The methodology page describes which fields feed into which output; this glossary entry documents the underlying term.

Source: FDA Recalls, Market Withdrawals and Safety Alerts, 2026.