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Glossary · Tier 1

Recall Classification

Also known as: recall class, FDA recall classification, recall designation

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

Recall classification is the system the U.S. Food and Drug Administration uses to rank product recalls by the level of health risk involved. The designation appears as a Roman numeral (I, II, or III), with Class I reflecting the most serious hazard and Class III the least. The verbatim regulatory definition follows below.

MedivaScan summary. The authoritative source quote follows below.

eCFR 21 CFR 7.3 definition

Recall classification means the numerical designation, i.e., I, II, or III, assigned by the Food and Drug Administration to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled.

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.