Product Recalls, Including Removals and Corrections: Guidance for Industry | Guideline Explorer

Description

This guidance document is intended to provide guidance and recommendations to FDA-regulated industry regarding what information firms should give to the Food and Drug Administration (FDA) and how they should notify their customers about product recalls. This guidance is intended to assist those members of industry regulated by the FDA in handling most aspects of a product recall, as well as some removals and corrections which do not meet the definition of a recall under 21 CFR 7.3. The guidance includes a checklist of documentation and information that industry can provide to the FDA that will be used by FDA to evaluate, classify, monitor and audit product recalls. Various statutory provisions and regulations, described below, authorize the FDA to require recalls of certain products in particular circumstances. Additionally, subpart C of part 7 of FDA regulations (21 CFR 7.40-59) provides general guidance for the voluntary recall of products, including those recalls initiated by a firm on its own and at the FDA's request. This guidance provides more specific recommendations and applies to voluntary and, to the extent that the guidance does not conflict with statute or regulation, mandatory recalls of all FDA-regulated products (i.e., food, including animal food; drugs, including animal drugs; medical and radiological devices and products; cosmetics; tobacco products; and biological products.)

Scope & Applicability

Product Classes

6

Infant formula

subject to 21 CFR parts 106 and 107

Infant Formulas

Subject to specific recall requirements under 21 U.S.C. 350a

Medical devices

Subject to mandatory recall provisions

Biological products

development program for drug and biological products

Medical Device

FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices

Electronic Product

Additional recommended information for Electronic Product notifications

Stakeholders

6

Division Recall Coordinator

FDA contact for recalling firms

Recall contact

Specific individual identified for recall communications

Consignee

The party receiving the imported goods, responsible for submitting evidence.

Bill to customers

Responsible for initiating sub-recalls

Recalling Firm

The entity responsible for conducting the recall

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Attributes

2

Expiration date

should be based on appropriate supportive stability data

Market shortage

Potential impact of a recall on consumers

Identified Hazards

Hazards

4

Health Hazard Assessment

Assessment of the health hazard associated with the violation

Health hazard

Relative degree of danger presented by the product

Chemical contaminant

Presence of cleaning fluid, machine oil, or paint vapors

Pathogen

Adulteration link that triggers DWPE.

Related CFR Sections (6)

21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR7.55§ 7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug Administration determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper Read full regulation →
21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
21CFR7.40§ 7.40 Recall policy.
(a) Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public healRead full regulation →
21CFR211.196§ 211.196 Distribution records.
Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product.Read full regulation →
21CFR117.139§ 117.139 Recall plan.
For food with a hazard requiring a preventive control:Read full regulation →

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