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# Recall Warning and Notification Guidance
- URL: https://www.fdaweb.com/recall-warning-and-notification-guidance/
- Published: 2018-01-18T12:00:00.000Z
- Updated: 2026-09-14T23:14:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Biologics, Drugs, Devices, #legacy-id-D5140538

FDA has issued a draft guidance, *Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C*, to assist and provide recommendations about the use, content, and circumstances for issuing public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C. The [document](https://www.fda.gov/downloads/safety/recalls/industryguidance/ucm592851.pdf?ref=fdaweb.com) also discusses what information should be included in a public warning, as well as the parties responsible for issuing it.

The guidance applies to voluntary recalls of products subject to FDA jurisdiction, the document says, including any food, drug, and device intended for human or animal use, any cosmetic and biologic intended for human use, any tobacco product intended for human use, and any item subject to a quarantine regulation under 21 CFR Part 1240.