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)
- 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