Industry Guidance For Recalls
Information on Recalls of FDA Regulated Products
General Recall Information (applicable to all commodities)
- Recalls Background and Definitions
- Recall Regulations in 21 CFR Part 7
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
- 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
- Using Electronic Means to Distribute Certain Product Information
- OII Recall Coordinators
Human Food and Animal Food Recalls
- Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls
- Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff
- Assisting Interested Parties in Addressing Marketplace Confusion Over the Identity of Food Products Subject to Recall
- Model Press Releases:
- Allergens (Allergy Alert)
- Listeria monocytogenes
- Clostridium botulinum
- Salmonella (all serotypes)
- E. coli 0157:H7
- Pet Food and Pet Treats
Medical Device Recalls
- NEW! FDA Form 5072: Device Correction/Removal Report for Industry (recommended submission tool for 21 CFR Part 806 reports)
- Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions
- Convenience Kit Reporting Requirements for Corrections, Removals, and Recalls, or Adverse Events
- Medical Device Recall Training Modules
- Medical Device Model Recall Notification Letter and Response Form
- Model Press Release: Medical Device
- Index of Generic Model Letter Exhibits (applicable to medical devices):
Human Drug Recalls
- Model Drug Recall Notification Letter and Response Form
- Model Press Release: Human Drug
- Index of Generic Model Letter Exhibits (applicable to drugs):