Industry Guidance For Recalls

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Recalls, Market Withdrawals, & Safety Alerts </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-14" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Industry Guidance For Recalls</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fsafety%2Frecalls-market-withdrawals-safety-alerts%2Findustry-guidance-recalls" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a 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data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b35b121a-6e7d-4e49-88ed-c0c946b36693" href="/media/170726/download?attachment" title="Medical Device Recalls and Reports of Corrections and Removals_ Part 7_ Part 806 FAQs">Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bb7425e8-c110-49a6-b829-914349cb051a" href="/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-questions-and-answers-regarding-mandatory-food-recalls" title="Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls">Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bb8b6fd5-f847-479d-921d-91f0ebde582b" href="/regulatory-information/search-fda-guidance-documents/initiation-voluntary-recalls-under-21-cfr-part-7-subpart-c" title="Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C">Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="668c091b-6926-4046-9ddb-1972804fb483" href="/regulatory-information/search-fda-guidance-documents/public-availability-lists-retail-consignees-effectuate-certain-human-and-animal-food-recalls" title="Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls">Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="40fac53e-c829-470a-b31e-295b9f0a6b95" href="/regulatory-information/search-fda-guidance-documents/public-warning-notification-recalls-under-21-cfr-part-7-subpart-c" title="Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C ">Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e88f2a45-83e8-4b17-8deb-970ccdb89aa7" href="/regulatory-information/search-fda-guidance-documents/product-recalls-including-removals-and-corrections" title="Product Recalls, Including Removals and Corrections">Industry Recall Guidance</a>: Product Recalls, Including Removals and Corrections</li> <li><a href="/safety/industry-guidance/recalls-background-and-definitions">Recalls Background and Definitions</a></li> <li><a href="https://www.ecfr.gov/cgi-bin/text-idx?SID=04040307f557c99107044cb17f41797f&mc=true&tpl=/ecfrbrowse/Title21/21cfr7_main_02.tpl">Recall Regulations in 21 CFR Part 7</a></li> <li>Index of Model Press Releases: <ul> <li><a href="/safety/industry-guidance/allergens-model-press-release">Allergens</a> (Allergy Alert)</li> <li><a href="/safety/industry-guidance/listeria-monocytogenes-model-press-release">Listeria monocytogenes</a></li> <li><a href="/safety/industry-guidance/c-botulinim-model-press-release">Clostridium botulinum</a></li> <li><a href="/safety/industry-guidance/salmonella-model-press-release-all-serotypes">Salmonella</a> (all serotypes) <ul> <li><a href="/safety/industry-guidance/salmonella-model-press-release-pet-food-and-pet-treats">Pet Food and Pet Treats</a></li> </ul> </li> <li><a href="/safety/industry-guidance/e-coli-0157h7-model-press-release">E. coli</a> 0157:H7</li> <li><a href="/safety/industry-guidance/medical-device-model-recall-news-release">Medical Device</a></li> <li><a href="/safety/industry-guidance/human-drug-model-press-release" target>Human Drug</a></li> </ul> </li> <li>Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual: <ul> <li>7-1 - <a href="/media/79098/download">Effectiveness Check Letter</a></li> <li>7-2 - <a href="/media/79117/download">Effectiveness Check Response Format</a></li> <li>7-3 - <a href="/media/79131/download">Effectiveness Check Questionnaire</a></li> <li>7-4 - <a href="/media/79108/download">Recall Letter</a></li> <li>7-5 - <a href="/media/79122/download">Recall Return Response Form</a></li> <li>7-6 - <a href="/media/79141/download">Recall Envelope</a></li> </ul> </li> <li><a href="/media/84668/download" target>Medical Device Model Recall Notification Letter and Response Form </a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="a7153573-071a-4837-89ab-2e1aaea0b737" href="/media/176507/download?attachment" target title="model_drug_notification_letter.pdf">Model Drug Recall Notification Letter and Response Form </a></li> <li><a href="/cdrhlearn" target>Medical Device Recall Training Modules</a></li> <li><a href="/safety/industry-guidance/assisting-interested-parties-addressing-marketplace-confusion-over-identity-products-subject-recall" target>Assisting Interested Parties in Addressing Marketplace Confusion Over the Identity of Food Products Subject to Recall</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/using-electronic-means-distribute-certain-product-information" target>Using Electronic Means to Distribute Certain Product Information</a></li> </ul> <p> </p> <p> </p> <br> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-10-01T00:00:00Z">10/01/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link">Industry Guidance For Recalls</a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section 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Industry Guidance For Recalls | FDA