Product Recall Procedure: Written Plan, Steps and Records (21 CFR Part 7)

General regulatory information for laboratory, clinic and supply staff, not legal advice and not individual medical advice.

Short answer

A product recall procedure is the written sequence a firm follows to remove or correct a marketed product: assess the hazard, classify it, decide the recall strategy, notify direct accounts, report status to FDA and close the recall. In the United States, 21 CFR Part 7 Subpart C sets the framework, and section 7.59 tells firms to keep a written contingency plan ready before any recall begins.

Definition and scope

FDA describes a recall as a firm’s action to remove a product from the market, started by the firm, at FDA’s request, or under an FDA order. Under 21 CFR 7.40, recall is a voluntary action: FDA may request one in urgent cases, and seizure or court action is possible if a firm refuses or the recall is ineffective.

This page covers the procedure, not the product-specific rules. For medical devices, see medical device recalls: classes, actions and records, and for the separate device correction and removal reporting rule see 21 CFR Part 806.

Recall procedure vs recall plan vs recall management

Recall plan

The plan is the document prepared in advance. Section 7.59 says to prepare and maintain a current written contingency plan for use in initiating and effecting a recall, to use lot coding so affected product can be positively identified, and to keep distribution records long enough to locate the product.

Recall procedure

The procedure is the ordered set of actions the plan commits the firm to once a problem is found. The table below maps each step to the section of Part 7 that governs it.

Recall management

Recall management is running the recall once it is open: sending notices, tracking responses, filing status reports and working toward termination. Section 7.53 covers periodic status reports, generally at an interval of 2 to 4 weeks, set by FDA according to the urgency of the recall, and 7.55 provides that FDA decides when a recall can be terminated.

Steps mapped to 21 CFR Part 7

Procedure step	What Part 7 says	Section
1. Evaluate the hazard	A health hazard evaluation supports the recall classification (Class I, II or III).	7.41
2. Set the strategy	The strategy addresses depth of recall, public warning and effectiveness checks.	7.42
3. Notify FDA	A firm that starts a recall is requested to notify the FDA district office promptly, with details such as the product, the reason and the distribution.	7.46
4. Notify direct accounts	The recalling firm is responsible for promptly notifying each affected direct account; the notice identifies the product, explains the hazard and gives handling instructions.	7.49
5. Report status	Periodic status reports, generally at an interval of 2 to 4 weeks.	7.53
6. Close the recall	FDA terminates when it determines reasonable efforts were made and the product was disposed of or corrected.	7.55
0. Prepare beforehand	Written contingency plan, lot coding, distribution records.	7.59

What a written recall plan contains

Part 7 does not prescribe a template, so the checklist below is an editorial reading of the sections above, with the source section beside each item.

• Lot coding that identifies each unit or batch (7.59). See lot codes.
• Distribution records that reach every direct account (7.59, 7.49).
• A named owner for the hazard evaluation and the classification discussion with FDA (7.41, 7.46).
• A notice that identifies the product by lot, code or serial number, explains the reason and hazard, and gives instructions for the product (7.49).
• A way for recipients to report back, and a log of who has answered (7.49, 7.42 effectiveness checks).
• A schedule for status reports and a file of what was sent (7.53).
• A test of the plan, such as a mock recall.

If you receive a recall notice (labs, clinics and purchasers)

Section 7.49 places the notification duty on the recalling firm and directs it to direct accounts, which is why a lab, clinic or reseller usually learns of a recall by letter. The notice is the source for what to do with the product. A buyer-side procedure can be built from the same records the firm is expected to keep:

1. Match the lot or code on the notice against your receiving and inventory records. Inventory records by lot make this possible.
2. Follow the handling instructions in the notice for the affected product; the notice, not this page, is the authority for what to do.
3. Use the reply mechanism the firm supplies so it can show the notice reached you.
4. Pass the notice on where the notice says to notify your own customers or sites.
5. Keep the notice, the lot match and your reply as a record.

Class labels at a glance

FDA classifies recalls by hazard: Class I is a reasonable probability of serious adverse health consequences or death; Class II is temporary or medically reversible adverse consequences, or serious harm is remote; Class III is unlikely to cause adverse health consequences. FDA assigns the class, not the firm. See Class III recalls and the Part 7 recall guide.

Common misunderstandings

“A recall is always ordered by FDA.”

Not under Part 7. Recalls are voluntary in form (7.40); a recall can be started by the firm, at FDA’s request, or under an FDA order.

“A market withdrawal is a recall.”

FDA treats a market withdrawal as a minor violation the agency would not pursue, which is different from a recall. A medical device safety alert refers to an unreasonable risk of substantial harm, and some of these are also recalls.

“A recall plan is only paperwork.”

The plan matters because it depends on lot coding and distribution records existing before a problem arises (7.59).

FAQ

What is a product recall procedure?

It is the written sequence of hazard evaluation, strategy, notification, status reporting and termination a firm follows to remove or correct a marketed product, framed in the US by 21 CFR Part 7 Subpart C.

What is a product recall plan?

It is the written contingency plan that 21 CFR 7.59 says firms should prepare and keep current so they can initiate and carry out a recall, supported by lot coding and distribution records.

What does recall management involve?

Running an open recall: notifying direct accounts (7.49), filing periodic status reports (7.53) and working toward termination (7.55). Regulators and firms may use their own terms for this phase.

Who must be notified in a recall?

The recalling firm must promptly notify each affected direct account (7.49) and, when the firm starts the recall, the appropriate FDA district office, which 7.46 asks the firm to notify.

Sources

• 21 CFR Part 7 Subpart C, Recalls (Including Product Corrections), sections 7.40, 7.41, 7.42, 7.46, 7.49, 7.53, 7.55, 7.59, eCFR, checked 2026-11-03; section text also at Cornell LII.
• FDA, Recalls Background and Definitions, checked 2026-11-03.