Definition

Drug Recall

A drug recall is the removal or correction of a marketed drug product that FDA considers to be in violation of the laws it administers, for example because it is contaminated, mislabeled, subpotent or made under deficient manufacturing controls.

2 min readReviewed September 14, 2026

Also known as: Medication recall, Pharmaceutical recall, FDA drug recall

Key facts

Regulation
21 CFR Part 7, Subpart C (recall policy and procedures)
Initiation
Usually voluntary, by the firm on its own or at FDA request
Hazard ranking
FDA Class I, II or III
Recall depth
Wholesale, retail or consumer level
Public record
Weekly FDA Enforcement Report

What is a drug recall?

A recall is the most common way a defective or violative drug leaves the market. The company that made or distributed the product notifies its customers, retrieves or corrects the affected units, and reports its progress to the Food and Drug Administration (FDA). Most drug recalls cover specific lots, not every unit of a drug.

Drug recalls are generally voluntary. A firm may start one after finding a problem, or FDA may request one. For most drugs FDA has limited authority to order a recall, so when a firm does not act the agency relies on public warnings and court actions such as seizure or injunction.

A recall is not the same as a market withdrawal, which removes a product for a minor violation that FDA would not pursue legally, or for a reason unrelated to a violation. A stock recovery covers product that has not left the direct control of the firm.

How a drug recall works

A typical recall moves through these steps:

  • Trigger: a defect found through testing, complaints, adverse event reports or an FDA inspection.
  • Health hazard evaluation: FDA assesses the risk and assigns Class I, II or III.
  • Recall strategy: the firm sets the depth (wholesale, retail or consumer level), whether a public warning is needed, and how effectiveness will be checked.
  • Notification: recall letters go to direct customers, and higher-risk recalls often get a press release.
  • Listing: FDA publishes the classified recall in the weekly Enforcement Report.
  • Termination: FDA ends the recall when it determines the firm has made all reasonable efforts to remove or correct the product.

Why drug recalls matter

Recalls affect operations, supply and competition:

Sources

All glossary terms