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Glossary · Tier 1

Class I Recall

Also known as: Class 1 Recall, Class I FDA Recall

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

Class I Recall is the highest tier in the FDA's three-level recall classification system. It is assigned to products where the agency determines that use of, or exposure to, the violative item carries a reasonable probability of serious harm or death. 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

Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

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.