Industry Guidance

Information on Recalls of FDA Regulated Products
FDA ORA/Office of Enforcement DCMO

Last Update: 2-6-2009

• Industry Recall Guidance: Product Recalls, Including Removals and Corrections
• Recalls Background and Definitions
• 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

• District Recalls Coordinators
• Index of Model Letter Exhibits in FDA Regulatory Procedures Manual, Chapter 7 "Recall Procedures"
  • 7-1 - Effectiveness Check Letter
  • 7-2 - Effectiveness Check Response Format
  • 7-3 - Effectiveness Check Questionnaire
  • 7-4 - Recall Letter (generic)
  • 7-5 - Recall Return Response Form
  • 7-6 - Recall Envelope