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Glossary · Tier 1

Class III Recall

Also known as: Class 3 Recall, Class III Drug Recall

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

Class III Recall is the least severe tier in the FDA's three-level recall classification framework. It applies to products that violate FDA regulations but are unlikely to pose a health risk to users. Common triggers include labeling errors, minor manufacturing deviations, or container defects that do not affect product safety or efficacy. The verbatim regulatory 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 III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

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.