VOLUNTARY FOOD RECALL NOTIFICATION

URGENT: FOOD RECALL NOTICE

PART 1: RECALL IDENTIFICATION

1.1 Recall Classification

Recall Type:
☐ Class I - Reasonable probability of serious adverse health consequences or death
☐ Class II - May cause temporary or medically reversible adverse health consequences
☐ Class III - Not likely to cause adverse health consequences

Recall Status:
☐ Firm-Initiated Voluntary Recall
☐ FDA-Requested Recall

Recall Number: [________________________________]

Recall Initiation Date: [__/__/____]

PART 2: RECALLING FIRM INFORMATION

2.1 Company Information

2.2 Recall Coordinator

PART 3: PRODUCT INFORMATION

3.1 Product Identification

3.2 Lot/Batch Information

3.3 Product Identification Marks

Location of Lot Code on Package: [________________________________]

Location of UPC Code: [________________________________]

Best By Date Format: [________________________________]

Other Identifying Marks: [________________________________]

PART 4: REASON FOR RECALL

4.1 Hazard Identification

Type of Hazard:
☐ Biological - Pathogen contamination
☐ Biological - Other: [________________________________]
☐ Chemical - Undeclared allergen
☐ Chemical - Foreign chemical contamination
☐ Chemical - Other: [________________________________]
☐ Physical - Foreign material
☐ Labeling - Incorrect/missing allergen declaration
☐ Labeling - Other: [________________________________]
☐ Other: [________________________________]

4.2 Specific Hazard Description

Contaminant/Hazard: [________________________________]

Potential Health Risk: [________________________________]

4.3 Allergen Information (if applicable)

Undeclared Allergen(s):
☐ Milk
☐ Eggs
☐ Fish: [________________________________]
☐ Shellfish: [________________________________]
☐ Tree Nuts: [________________________________]
☐ Peanuts
☐ Wheat
☐ Soybeans
☐ Sesame
☐ Other: [________________________________]

4.4 How Hazard Was Discovered

☐ Consumer complaint
☐ Internal testing
☐ Third-party laboratory testing
☐ Supplier notification
☐ FDA notification
☐ State agency notification
☐ Illness report
☐ Other: [________________________________]

Date Discovered: [__/__/____]

Discovery Details: [________________________________]

PART 5: DISTRIBUTION INFORMATION

5.1 Distribution Scope

Distribution Area:
☐ Nationwide
☐ Regional - States: [________________________________]
☐ Local - Area: [________________________________]
☐ International - Countries: [________________________________]

Distribution Dates: [__/__/____] to [__/__/____]

5.2 Distribution Channels

☐ Retail stores
☐ Wholesale distributors
☐ Food service/restaurants
☐ Online/direct to consumer
☐ Institutional (schools, hospitals)
☐ Other: [________________________________]

5.3 Quantity and Distribution Summary

PART 6: CONSIGNEE NOTIFICATION

6.1 Recall Communication to Consignees

[LETTERHEAD]

Date: [__/__/____]

URGENT: FOOD RECALL NOTIFICATION

Dear Valued Customer:

[________________________________] is voluntarily recalling the following product(s) due to [________________________________].

PRODUCT(S) BEING RECALLED:

REASON FOR RECALL:

[________________________________]

HEALTH RISK:

[________________________________]

ACTION REQUIRED:

Please take the following immediate actions:

1. ☐ Stop sale/distribution of the recalled product immediately
2. ☐ Remove recalled product from shelves/inventory
3. ☐ Segregate and quarantine all recalled product
4. ☐ Do not destroy product until instructed
5. ☐ Complete and return the enclosed response form by [__/__/____]
6. ☐ Extend this recall notice to your customers/sub-consignees

PRODUCT DISPOSITION:

☐ Hold for pickup/return to [________________________________]
☐ Return to: [________________________________]
☐ Destroy according to the following instructions: [________________________________]
☐ Credit will be issued upon: [________________________________]

CONTACT INFORMATION:

For questions, contact:
Name: [________________________________]
Phone: [________________________________]
Email: [________________________________]

Please confirm receipt of this notice and your inventory status using the attached response form.

Sincerely,

[________________________________]
[________________________________]
[________________________________]

PART 7: CONSIGNEE RESPONSE FORM

Recall Response Form

Please complete and return by: [__/__/____]

Return to: [________________________________]

Fax: [________________________________] Email: [________________________________]

Consignee Information:

Product Inventory Status:

☐ We have NONE of the recalled product in our possession
☐ We NEVER received any of the recalled product
☐ We have the recalled product and have taken the following action:
[________________________________]

Sub-Consignee Notification:

☐ N/A - We did not distribute to others
☐ We have notified all of our customers/sub-consignees

Number of sub-consignees notified: [____]

Authorized Signature: ________________________________________

Date: [__/__/____]

PART 8: PUBLIC NOTIFICATION (Press Release)

8.1 Press Release Template

FOR IMMEDIATE RELEASE

Date: [__/__/____]

Contact: [________________________________]
Phone: [________________________________]
Email: [________________________________]

[COMPANY NAME] VOLUNTARILY RECALLS [PRODUCT NAME] DUE TO [REASON]

[City, State] - [________________________________] is voluntarily recalling [________________________________] because [________________________________].

Product Details:
- Product Name: [________________________________]
- Package Size: [________________________________]
- UPC Code: [________________________________]
- Lot Numbers: [________________________________]
- Best By Dates: [________________________________]
- Distribution: [________________________________]

Reason for Recall:

[________________________________]

What Consumers Should Do:

Consumers who have purchased [________________________________] should [________________________________].

Consumers with questions may contact [________________________________] at [________________________________] during [________________________________].

Illness Reports:

[________________________________]

About [Company Name]:

[________________________________]

PART 9: FDA NOTIFICATION

9.1 Report to FDA

Reportable Recall Submission

☐ Submitted to FDA Recall Coordinator
☐ Submitted via FDA Safety Reporting Portal
☐ Submitted to local FDA District Office

FDA District Office: [________________________________]

Date Submitted: [__/__/____]

FDA Contact: [________________________________]

9.2 Information Provided to FDA

☐ Identity of the product
☐ Reason for the recall and hazard involved
☐ Extent of distribution (dates, geographic area, consignees)
☐ Copy of recall communication
☐ Number of direct accounts
☐ Proposed strategy for recall

PART 10: RECALL EFFECTIVENESS CHECKS

10.1 Effectiveness Check Plan

Level of Effectiveness Checks:
☐ Level A - 100% of consignees
☐ Level B - >10% of consignees
☐ Level C - 10% of consignees
☐ Level D - 2% of consignees
☐ Level E - No effectiveness checks

Method of Effectiveness Checks:
☐ Phone calls
☐ Personal visits
☐ Letters requiring response
☐ Combination

Frequency: [________________________________]

10.2 Effectiveness Check Log

10.3 Recall Status Summary

PART 11: PRODUCT DISPOSITION

11.1 Disposition Method

☐ Return to manufacturer
☐ Destruction at consignee location
☐ Destruction at designated facility
☐ Reconditioning/reprocessing
☐ Conversion to non-food use

11.2 Destruction Documentation

PART 12: RECALL TERMINATION

12.1 Recall Completion Criteria

☐ All known consignees have been notified
☐ Effectiveness checks completed to required level
☐ All recoverable product has been accounted for
☐ Product properly disposed of
☐ FDA notified of recall completion

12.2 Recall Termination Request

Date Recall Completed: [__/__/____]

Final Statistics:

IMPORTANT REGULATORY NOTES

Recall Classifications (21 CFR 7.41)

• Class I: Health hazard situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death
• Class II: Health hazard situations where use may cause temporary or medically reversible adverse health consequences
• Class III: Not likely to cause adverse health consequences

Required Actions Under 21 CFR Part 7

• Notify FDA of firm-initiated recalls
• Prepare and distribute recall communications
• Conduct effectiveness checks
• Maintain records of recall activities

FSMA Requirements (21 CFR 117.139)

• Written recall plan required for facilities with hazards requiring preventive controls
• Plan must include procedures for consignee notification, public notification (if appropriate), effectiveness checks, and product disposition

SOURCES AND REFERENCES

• 21 CFR Part 7 Subpart C - Recalls
• 21 CFR 117.139 - Recall Plan
• FDA Guidance: Initiation of Voluntary Recalls Under 21 CFR Part 7
• FDA Guidance: Public Warning and Notification of Recalls
• FDA Regulatory Procedures Manual Chapter 7

This template is provided for informational purposes only. Each recall must be tailored to the specific product and circumstances involved. Follow your facility's written recall plan and consult with FDA regulatory counsel.