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Public Warning and Notification of Recalls Under Part 7

This guidance provides recommendations for industry and FDA staff regarding public warnings and notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C. It applies to voluntary recalls of FDA-regulated products including food, drugs, devices, cosmetics, biologics, and tobacco products, but excludes radiation-emitting electronic products.

  1. Develop a recall strategy that includes criteria for issuing public warnings
  2. Create templates for public warnings that include all required information
  3. Establish processes to issue public warnings within 24 hours when requested by FDA
  4. Set up distribution channels for public warnings matching product distribution
  5. Monitor media coverage of issued warnings and take additional actions if coverage is insufficient
  6. Maintain documentation of all recall communications and public warnings
  7. Ensure public warnings remain accessible until product is no longer expected to be used
  8. Consider translation needs based on product user demographics
  9. Establish process to verify receipt of recall communications by business accounts
  10. Monitor FDA Enforcement Report for accuracy of recall information

Key Considerations

Safety

  • Public warnings are required for urgent situations where products present serious health hazards
  • Class I recalls generally require public warnings unless specific circumstances indicate otherwise
  • Some urgent Class II recalls may require public warnings if presenting serious health hazards
  • Public warnings should be issued within 24 hours of FDA notification
  • The warning must include product identification, geographic distribution, defect description, health hazard details, and contact information

Other considerations

  • Firms should develop their own recall strategy including public warning plans
  • FDA may issue its own warning if a firm’s warning is deficient or not issued
  • Public warnings should be distributed to match product distribution (regional/national)
  • Translations may be needed for non-English speaking populations
  • All recalls will be listed in the FDA Enforcement Report regardless of hazard level

    Relevant Guidances

  • Product Recalls, Removals, and Corrections: Procedures and Best Practices
  • 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities
  • 21 CFR Part 1240: Control of Communicable Diseases

Original guidance

  • Public Warning and Notification of Recalls Under Part 7
  • HTML / PDF
  • Issue date: 2019-02-08
  • Last changed date: 2023-09-29
  • Status: FINAL
  • Official FDA topics: Tobacco, Medical Devices, Food & Beverages, Investigation & Enforcement, Drugs, Animal & Veterinary, Biologics, Recalls
  • ReguVirta summary file ID: 8103994b53d6ad78251bf4cc68723816
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