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Glossary · Tier 1

Recall

Also known as: drug recall, product recall, FDA recall

Verified from eCFR 21 CFR 7.3 on 06-02-2026
Quick answer

In FDA terminology, a recall is a formal action taken by a firm to remove or correct a marketed product that the agency considers to be in violation of the laws it enforces. The term has a specific regulatory meaning and does not cover every removal of a product from the market. The verbatim definition from the U.S. Office of the Federal Register follows below.

MedivaScan summary. The authoritative source quote follows below.

eCFR 21 CFR 7.3 definition

Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

U.S. Office of the Federal RegisterView on source ›Verbatim quote. Last verified 06-02-2026.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.