Skip to content
ContentLora

    Tip: press / anywhere to search.

    concept

    FDA recall process: Class I, II and III recalls explained

    Also known as FDA recall, drug recall, recall classification, FDA Enforcement Report

    US recalls of drugs and other FDA-regulated products may be started by the company on its own initiative, at FDA's request, or by FDA order.[1] FDA then classifies each recall by hazard, from Class I (reasonable probability of serious harm or death) to Class III (harm unlikely), and lists it in its weekly Enforcement Report.[2][3][4]

    Editor reviewedStrict sourcingUpdated WikiHealth and medicine, Tech policy
    Key facts

    A US product recall is an action by a firm to remove a product from the market. Recalls may happen on a firm’s own initiative, at FDA’s request, or by FDA order under statutory authority.[1] For medicines, FDA describes a recall as a voluntary action by a company to remove a defective drug or warn patients about a potential risk.[5] Recent eye drop recalls show how the process works in practice; see eye drop recalls tracker.[6]

    Recall classes

    FDA assigns each recall a class according to the hazard.[4]

    ClassFDA definitionEye drop example
    IReasonable probability of serious harm or death[2]EzriCare artificial tears, 2023[7]
    IITemporary or medically reversible harm possible, or serious harm remote[8]Clear Eyes Redness Relief, 2026[9]
    IIIHarm not likely[3]None among the eye drop recalls on this site

    A market withdrawal is different: it covers a minor violation that would not be subject to FDA legal action.[10]

    From firm action to Enforcement Report

    Most of the time FDA sets the classification after the recalling firm has provided all the information needed to judge the risk.[4] Firms often announce voluntary recalls well before that, so news of a recall can come before FDA’s listing.[11] For example, Sterling Pharmaceutical Services began its eye drop recall on 20 August 2026, FDA classified it on 21 September and posted it on 30 September.[6] Since 15 June 2017 FDA has also listed recalls that are still pending classification, to alert the public sooner.[12]

    When FDA judges that all reasonable efforts have been made to remove or correct a product, it marks the recall terminated.[13]

    Where recalls are published

    • Enforcement Report: lists all recalls FDA monitors, available as a weekly report, through quick and advanced search, and through an API.[4][14]
    • Email alerts: FDA lets users subscribe to Enforcement Report notifications by product type or keyword, such as a brand or “sterility”.[15]
    • Recalls, Market Withdrawals and Safety Alerts page: lists recalls that have press releases or public notices. FDA notes that not all recalls appear there.[16]

    Recalls and dietary supplements

    Dietary supplements sit under a different framework. Under the Dietary Supplement Health and Education Act, FDA cannot approve supplements before they are marketed, but makers must follow good manufacturing practice rules.[17][18] FDA inspects manufacturers and issues warning letters, such as a February 2026 letter that found a company’s creatine manufacturing record inadequate.[19] See creatine buyer’s guide for how this affects buyers.[17]

    Reporting problems

    FDA encourages patients and health care professionals to report adverse events or quality problems with medicines to MedWatch.[20] This page explains the process and is not medical advice; anyone worried about a recalled product they have used should talk to a clinician or pharmacist.[21]

    Next in the crash course

    More in Health & medicine

    Developing in Health

    Questions readers ask

    Who decides to recall a drug in the US?

    Recalls may be carried out on a firm's own initiative, at FDA's request, or by FDA order under statutory authority. FDA describes drug recalls as voluntary actions by companies.[1][5]

    What is the difference between Class I, II and III recalls?

    Class I means a reasonable probability of serious harm or death. Class II means the product may cause temporary or medically reversible harm, or serious harm is remote. Class III means harm is not likely.[2][8][3]

    Why is a recall in the news before FDA lists it?

    Firms often announce voluntary recalls well before FDA finishes classifying them and posts them to the Enforcement Report.[11]

    What is a market withdrawal?

    A market withdrawal is when a firm removes or corrects a product with a minor violation that would not be subject to FDA legal action.[10]

    What does "terminated recall" mean?

    FDA marks a recall terminated when it has determined that all reasonable efforts have been made to remove or correct the product and proper disposition has been made.[13]

    Sources

    · 21 claims from 3 publishers

    Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.

    1. [1]

      FDA describes a recall as a firm's action to remove a product from the market, conducted on the firm's own initiative, at FDA's request, or by FDA order under statutory authority. confirmedas of 2026-10-11

    2. [2]

      A Class I recall is a situation where there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death. confirmedas of 2026-10-11

    3. [3]

      A Class III recall is a situation where using or being exposed to the product is not likely to cause adverse health consequences. confirmedas of 2026-10-11

    4. [4]

      The FDA Enforcement Report lists all recalls monitored by FDA once they are classified, and recall classifications are usually set after the firm supplies the information FDA needs to assess the risk. confirmedas of 2026-10-11

    5. [5]

      FDA describes a drug recall as a voluntary action by a company to remove a defective drug from the market or warn patients and consumers about a potential risk. confirmedas of 2026-10-11

      • Drug Recalls · US Food and Drug Administration (retrieved 2026-10-11)
    6. [6]

      Sterling Pharmaceutical Services of Dupo, Illinois, began a nationwide recall of eye-care products on 20 August 2026 for lack of assurance of sterility; FDA classified it Class II on 21 September and posted it on 30 September 2026. confirmedas of 2026-10-11

    7. [7]

      FDA classified the EzriCare and Delsam Pharma artificial tears recall as Class I after its analysis found bacterial contamination in unopened products; the recall covered 400,008 bottles. confirmedas of 2026-10-11

    8. [8]

      A Class II recall is a situation where the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote. confirmedas of 2026-10-11

    9. [9]

      Insight Pharmaceuticals, a Prestige Consumer Healthcare company, began a nationwide recall of Clear Eyes Redness Relief eye drops on 15 September 2026 for lack of assurance of sterility; FDA classified it Class II on 23 September and posted it on 30 September 2026, listing 2,356,248 bottles. confirmedas of 2026-10-11

    10. [10]

      FDA defines a market withdrawal as the removal or correction of a product with a minor violation that would not be subject to FDA legal action. confirmedas of 2026-10-11

    11. [11]

      FDA notes that firms often announce voluntary recalls well before FDA completes its classification and posts the recall to the Enforcement Report. confirmedas of 2026-10-11

    12. [12]

      Since 15 June 2017 the Enforcement Report has also listed recalls that are pending classification, to alert the public sooner. confirmedas of 2026-10-11

    13. [13]

      FDA calls a recall terminated when it has determined that all reasonable efforts have been made to remove or correct the product and proper disposition has been made. confirmedas of 2026-10-11

    14. [14]

      Enforcement Report data can be accessed through a weekly report, quick and advanced search, and an application programming interface (API). confirmedas of 2026-10-11

    15. [15]

      FDA offers email notifications of new and updated recalls in the Enforcement Report, including alerts by keyword such as a brand name or a recall reason like "sterility". confirmedas of 2026-10-11

    16. [16]

      FDA's Recalls, Market Withdrawals and Safety Alerts page lists recalls drawn from press releases and public notices, and FDA states that not all recalls have press releases or appear there. confirmedas of 2026-10-11

    17. [17]

      Under the Dietary Supplement Health and Education Act, FDA does not have the authority to approve dietary supplements before they are marketed. confirmedas of 2026-10-11

    18. [18]

      FDA regulations require supplement makers, packers and holders to follow current good manufacturing practices meant to ensure the identity, purity, quality, strength and composition of supplements. confirmedas of 2026-10-11

    19. [19]

      In a 10 February 2026 warning letter, FDA told supplement maker Hearthy Foods that the master manufacturing record it supplied for its Creatine Powder was inadequate under federal manufacturing rules. confirmedas of 2026-10-11

    20. [20]

      FDA encourages patients and health care professionals to report adverse events or quality problems with medicines to its MedWatch program. confirmedas of 2026-10-11

    21. [21]

      CDC advised that people who had used the recalled products and had signs or symptoms of an eye infection should seek medical care immediately. confirmedas of 2023-05-15

    Revision history (1)
    1. Page created.

    Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Apr 11, 2027.

    Cite this page

    "FDA recall process: Class I, II and III recalls explained." ContentLora, updated Oct 11, 2026. https://contentlora.com/wiki/fda-recall-process

    Spotted an error? Suggest a correction or emailcorrections@contentlora.com.

    ☰ Contents