21 CFR Part 117 · Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

21 CFR 117.139

Recall plan

21 CFR 117.139 is the regulation titled “Recall plan” in 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Since 2021, 1 FDA warning letter has cited it.

Letters citing it
1 since 2021
Jan 1 to Oct 30, 2026
0 against 0 on the same dates in 2025
Most often cited with
21 CFR 101.3, in 1 letter
Closed out
100% of these letters have a published close-out
See the letter citing 21 CFR 117.139 →

Letters citing it, by year issued

It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.

  1. 02021
  2. 02022
  3. 12023
  4. 02024
  5. 02025
  6. 02026

The regulation

Read the text of 21 CFR 117.139 (eCFR, as of Sep 1, 2026)

For food with a hazard requiring a preventive control:

(a) You must establish a written recall plan for the food.

(b) The written recall plan must include procedures that describe the steps to be taken, and assign responsibility for taking those steps, to perform the following actions as appropriate to the facility:

(1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;

(2) Notify the public about any hazard presented by the food when appropriate to protect public health;

(3) Conduct effectiveness checks to verify that the recall is carried out; and

(4) Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

Text from eCFR as of Sep 1, 2026.

Cited alongside it

Regulations that appear in the same letters as 21 CFR 117.139.

Latest letters citing it

The letter citing 21 CFR 117.139 that FDA posted most recently.

See the letter citing 21 CFR 117.139 →
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