Industry Guidance For Recalls

Information on Recalls of FDA Regulated Products

         OII Recall Coordinators

• NEW! Convenience Kit Reporting Requirements for Corrections, Removals, and Recalls, or Adverse Events
• NEW! Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions
• Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls
• Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
• Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff
• Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff
• Industry Recall Guidance: Product Recalls, Including Removals and Corrections
• Recalls Background and Definitions
• Recall Regulations in 21 CFR Part 7
• Index of Model Press Releases:
  • Allergens (Allergy Alert)
  • Listeria monocytogenes
  • Clostridium botulinum
  • Salmonella (all serotypes)
    • Pet Food and Pet Treats
  • E. coli 0157:H7
  • Medical Device
  • Human Drug
• Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual:
  • 7-1 - Effectiveness Check Letter
  • 7-2 - Effectiveness Check Response Format
  • 7-3 - Effectiveness Check Questionnaire
  • 7-4 - Recall Letter
  • 7-5 - Recall Return Response Form
  • 7-6 - Recall Envelope
• Medical Device Model Recall Notification Letter and Response Form
• Model Drug Recall Notification Letter and Response Form
• Medical Device Recall Training Modules
• Assisting Interested Parties in Addressing Marketplace Confusion Over the Identity of Food Products Subject to Recall
• Using Electronic Means to Distribute Certain Product Information