Description
The purpose of this guidance is to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. The guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations firms in the distribution chain should consider making to ensure timely responses to a recall communication. Additionally, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA.
Scope & Applicability
Product Classes
4Electronic products subject to 21 CFR part 892.
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
The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
Stakeholders
7Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
individual responsible for evaluating potential risks
first level of distribution notified by the recalling firm
Entity involved in investigational drug supply chain
The receiving distributor who provides an acknowledgment letter.
The firm that initiates a recall or has primary responsibility for manufacture and marketing.
headed by a recall coordinator
Regulatory Context
Attributes
1wholesale, retail, or consumer level
Identified Hazards
Hazards
2Notifying the public about a product presenting a health hazard
Basis for FDA requesting a product recall
Related CFR Sections (11)
- 21CFR7.45§ 7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or designee may request a firm to initiate a recall when the following determinations have been made:Read full regulation →
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
- 21CFR7.49§ 7.49 Recall communications.
(a) General. A recalling firm is responsible for promptly notifying each of its affected direct accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In genRead full regulation →
- 21CFR7.46§ 7.46 Firm-initiated recall.
(a) A firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate Food and Drug Administration district office listed in § 5.115 of tRead full regulation →
- 21CFR7.42§ 7.42 Recall strategy.
(a) General.Read full regulation →
- 21CFR806.10§ 806.10 Reports of corrections and removals.
(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:Read full regulation →
- 21CFR507.38§ 507.38 Recall plan.
(a) For animal food with a hazard requiring a preventive control you must:Read full regulation →
- 21CFR117.139§ 117.139 Recall plan.
For food with a hazard requiring a preventive control:Read full regulation →
- 21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
- 21CFR7.59§ 7.59 General industry guidance.
A recall can be disruptive of a firm's operation and business, but there are several steps a prudent firm can take in advance to minimize this disruptive effect. Notwithstanding similar specific requirements for certain products in other parts of this chapter, the following is provided by the Food aRead full regulation →
- 21CFR211.192§ 211.192 Production record review.
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (inRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
Turbare Manufacturing
- 2025-12-02
CGMP/Finished Pharmaceuticals/Adulterated
Rhyz Analytical Labs
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-11-18
Nonprescription/OTC
DermaRite Industries, LLC
- 2025-11-04
CGMP/Finished Pharmaceuticals/Adulterated
Liebel-Flarsheim Company LLC
- 2025-11-04
CGMP/Finished Pharmaceuticals/Adulterated
Apotex Inc.
- 2025-10-07
CGMP/Finished Pharmaceuticals/Adulterated
Naturich Cosmetique Labs
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products (Status: Final)
- Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)