Industry Guidance For Recalls

The following is published for the FDA Industry Guidance Covering Information on Recalls of FDA Regulated Products
Published March 3, 2022

Information on Recalls of FDA Regulated Products

• 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

• ORA Recall Coordinators
• 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
• Medical Device Recall Training Modules
• Assisting Interested Parties in Addressing Marketplace Confusion Over the Identity of Food Products Subject to Recall

Read Full FDA Safety Recalls Market Withdrawal Safety Alerts Industy Guidance Recalls.