{"id":353260,"date":"2016-04-04T10:46:44","date_gmt":"2016-04-04T15:46:44","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/fda-recall-types.html"},"modified":"2023-11-08T16:22:42","modified_gmt":"2023-11-08T21:22:42","slug":"fda-recall-types","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/fda-recall-types.html","title":{"rendered":"FDA Recall Types"},"content":{"rendered":"\n<div class=\"wp-container-core-columns-is-layout-9d6595d7 fl-sectionWithSidebar fl-container fl-flex fl-flex-wrap fl-gap30\">\n<div class=\"fl-page-articles fl-section-main fl-section-main-full-width\"><h1 class=\"fl-no-margin-top\">FDA Recall Types<\/h1>\n\n<section class=\"fl-gutenberg-byline\">\n    <div class=\"fl-gutenberg-byline-content\">\n                    By <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/christie-nicholson-j-d\/\">Christie Nicholson, J.D.<\/a> | Legally reviewed by <a\n                href=\"https:\/\/www.findlaw.com\/company\/our-team\/oni-harton-j-d\/\">Oni Harton, J.D.<\/a>\n                | Last reviewed\n        <time>\n                            November 08, 2023\n                    <\/time>\n    <\/div>\n\n    \n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-legally-reviewed\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Legally Reviewed\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>This article has been written and reviewed for legal accuracy, clarity, and style by <a href=\"https:\/\/www.findlaw.com\/company\/our-team.html\">FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with <a href=\"https:\/\/www.findlaw.com\/company\/company-history\/editorial-policy.html\">our editorial standards<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n\n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-fast-checked\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Fact-Checked\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>The last updated date refers to the last time this article was reviewed by FindLaw or one of our <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/contributing-authors.html\">contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please <a href=\"https:\/\/lawyers.findlaw.com\/?fli=bylinelink\" target=\"_blank\" rel=\"noopener\">contact an attorney in your area<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n<\/section>\n\n\n    <div class=\"fl-callout-text article-blockquote\">\n        <div data-testid=\"loading-message\">\n<div>\n<div id=\"chatMessageResponser4p\" class=\"___1yop6mf f336tjw f9ijwd5 fz7g6wx fod5ikn f1s184ao\" aria-live=\"assertive\">\n<div class=\"___1j4t0a1 f1lmfglv f1abmfm4\" aria-hidden=\"false\" data-testid=\"markdown-reply\" data-message-type=\"Chat\">\n<div class=\"___stpibi0 f22iagw f1vx9l62 fk15e71 f1k953kz f137keqj f1rncccw f1stllg3 f1w4kmmc f1tric3v f10dk5ic fx8cdsv f16nlwsl f1eookvz fhjrts3 fqugt2f f10km5jb f18d18k8 f1v1vhmp f1hdmul3 f198vjnp f2dshw1 fjpjndq fnmj2pj ffrrb40 f1mon110 fhajzam fimndk6 fxv4dng fb1rn9k f59wlhv f1xmfh30 f18yf5o5 fmr6chf fw8qy2q ff161sd f1qr7t77 f1yyogn1 foogchg fp5872b f1tpb8gf f1hdgrc8 f1vatr43 frkxccd f9pdzkb f158oiaz ft5kggy f5l4ui7 f13j03li f18xdoka f8off4e f1go6zfc f128n2ra f1jpxw2j f1lwd9n0 fy0b8hm f1g2633v fx4kvgi fkvolse f1gxrt3a f1os76ua f1js9cnw f1g87ej0 freluf8 f1yggaq6 f2i3chp f1151osp florpoh f35kzfz ftp9m57 f1e288vi fz62hnz fixvuys f1nmofwh fc1c6mv f18a2er7 fhvkrdl fhxnn68 f1oce4bo fvhlfan f7tc0t0 f1ngf1n2 ffrzq6x f1yjiq2m f1aqdgql f1huvaf f10ij78l f1k94sa4 fkmfumq f1jvzkyl f1eu24ob f1xbfc1f fmf0lwf f107dsy8 f3w566c f4648sl f13zpkng f7unjfp f8p1rz fzu6h1w f1i1bi6h f1smo7hi f1sk1xod f1kgogdq f1gjktkp ft608jz f19dd9cz fg3xr24 fhd155k f1b8gl2e fg4b9ou flb4lo fdicbfk fgwcyh1 f1jbds0d f1fb9uea f1stuka4 fcrtu6g fwqh0xn f11w66yg f6e0e65 f1vvgu0 f1607507 f1m9bycv f1ntoah8 f1b694rt faql4r2 fpjuhzh fmavl6h\">\n<p>The FDA oversees product recalls to protect public health, classifying them into three categories based on severity. Recalls may be initiated voluntarily by manufacturers or mandated by the FDA, which monitors the process and may issue public warnings.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div><\/div>\n<div><\/div>\n<\/div>\n<\/div>\n\n    <\/div>\n\n\n\n<p>A product recall is a notice to the public and consumers that a product is unsafe. The <a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">U.S. Food and Drug Administration<\/a> (FDA) and product manufacturers initiate recalls. Most recalls apply to consumer goods, but that isn&#8217;t always true. For example, the FDA or manufacturers may recall a dangerous drug or defective medical device.<\/p>\n<p>Recalls occur in one of two ways. The company may issue a voluntary recall of their products if they think they pose a danger to public health. Or the FDA (<a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">FDA.gov<\/a>) can demand that manufacturers issue a recall.<\/p>\n<p>In either case, the FDA monitors the recall process and consults with the company regarding the recall&#8217;s effectiveness. It also determines whether products are safe enough to reenter the market.<\/p>\n<p>This article discusses how FDA recalls work, the types of recalls, and what to do if you get hurt using a recalled product.<\/p>\n<p>If you&#8217;ve been harmed by a recalled product, you have legal options. Contact a <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/\" target=\"_blank\" rel=\"noopener\">product liability lawyer<\/a> near you to understand your rights. An experienced attorney can determine whether you have a valid claim and advise on next steps to pursue compensation.<\/p>\n<h2>FDA Recall Procedures<\/h2>\n<p>The recall process begins when the FDA learns its regulated product may be dangerous to public health. There are several ways the FDA can find out about hazardous products. These include the following:<\/p>\n<ul>\n<li>The manufacturer discovers a defect and contacts the FDA<\/li>\n<li>The FDA receives reports of health problems stemming from a particular product<\/li>\n<li>The\u00a0<a href=\"https:\/\/www.cdc.gov\/foodsafety\/outbreaks\/steps\/index.html\" target=\"_blank\" rel=\"noopener\">Centers for Disease Control<\/a>\u00a0(CDC) notices a trending health problem related to an FDA-regulated product<\/li>\n<li>FDA employees inspect the manufacturer&#8217;s factory and determine that there is a likelihood that problems will arise<\/li>\n<\/ul>\n<p>Once the FDA determines a recall is necessary, it works with the manufacturer to <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/why-drugs-get-pulled-from-the-market.html\">remove the product<\/a> from stores, hospitals, and doctors&#8217; offices. Many times, this happens without any public notification.<\/p>\n<p>The\u00a0<a href=\"https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\" target=\"_blank\" rel=\"noopener\">FDA only alerts the media<\/a>\u00a0in cases where the potential harm from the product is serious. But all product recalls are<a href=\"http:\/\/www.fda.gov\/forconsumers\/consumerupdates\/default.htm\" target=\"_blank\" rel=\"noopener\">\u00a0available on the FDA&#8217;s website<\/a>. You can also <a href=\"https:\/\/www.fda.gov\/about-fda\/contact-fda\/get-email-updates\" target=\"_blank\" rel=\"noopener\">sign up for a newsletter<\/a>\u00a0about FDA recall information and get the safety alerts sent directly to you.<\/p>\n<p>The FDA issues a public warning by listing the product and brand name. They also list the reason for the recall. For example, the FDA may report undeclared ingredients (like nuts) or specific bacteria detected (like salmonella).<\/p>\n<p>The FDA also provides an<a href=\"https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/enforcement-reports\" target=\"_blank\" rel=\"noopener\">\u00a0FDA Enforcement Report<\/a>, which determines the recall strategy. This may be market withdrawal or label correction.<\/p>\n<h2>What Is a Partial Recall?<\/h2>\n<p>Sometimes, the FDA only recalls specific batches of a product. If only one lot number contains damaged or defective products, the manufacturer doesn&#8217;t have to recall all units.<\/p>\n<p>When the FDA issues a partial recall, it will provide the manufacturer with instructions on identifying the defective units. For example, it may give the company a date range to check. Or it may provide the company with a list of specific lots with defective units.<\/p>\n<h2>Recall Classifications<\/h2>\n<p>The FDA splits its\u00a0<a href=\"https:\/\/www.fda.gov\/safety\/industry-guidance-recalls\/recalls-background-and-definitions\" target=\"_blank\" rel=\"noopener\">product recalls into classes<\/a>: Class I, II, and III. The FDA categorizes products based on the potential for injury. Class I recalls are the most serious. This is for products that may seriously harm or kill a consumer. Class III includes products that may pose a risk to specific (but not all) consumers.<\/p>\n<p>Descriptions of the classes are as follows:<\/p>\n<ul>\n<li><b>Class I<\/b>: Recalls for products that could cause severe injury or death<\/li>\n<li><b>Class II<\/b>: Recalls for products that might cause significant injury or temporary illness<\/li>\n<li><b>Class III<\/b>: Recalls for products that are unlikely to cause injury or illness but violate FDA regulations<\/li>\n<\/ul>\n<p>When the FDA notifies the public of a recall, they will identify which class of recall the product falls into.<\/p>\n<h3>Class I Recalls<\/h3>\n<p>Class I recalls apply to products that pose a serious risk to consumers. Many of these recalls are for products that can (or have) caused death. Some <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/car-defects-and-recalls-basics.html\">vehicle recalls<\/a> fall into this category. For example, a vehicle defect that causes the car to catch fire qualifies as a Class I recall.<\/p>\n<p>Some <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/dangerous-drugs.html\">dangerous drugs<\/a> can also fall into this category. For instance, if the FDA learns a particular medication causes cancer, it will likely categorize it as a Class I recall.<\/p>\n<h3>Class II Recalls<\/h3>\n<p>Class II recalls involve products that can cause severe injury or temporary illness. This wouldn&#8217;t apply to drugs that cause cancer. Nor would it apply to <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/drugs-and-medical-device-recalls.html\">medical devices<\/a> that cause serious bodily harm.<\/p>\n<p>A prime example of a Class II recall would be a toy that presents a choking hazard to <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/lead-in-toys-and-lead-poisoning-in-children.html\">young children<\/a>. While not all children who swallow a small component of a toy will choke and die, there is a risk that children will suffer serious injury.<\/p>\n<h3>Class III Recalls<\/h3>\n<p>Most FDA and manufacturer recalls fall into this category. In these cases, the product isn&#8217;t likely to harm anybody. However, the item does violate FDA regulations. An example of this could be a product that doesn&#8217;t include adequate warnings. A vehicle whose <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/get-legal-help-with-a-car-or-vehicle-defect-or-recall.html\">rear brake lights burn out too quickly<\/a> could be a Class III recall.<\/p>\n<h2>What Should I Do if I Have a Recalled Product?<\/h2>\n<p>If you discover that the FDA recalls a product you own, don&#8217;t panic. Research the recall on the FDA&#8217;s website. You can also find information on the manufacturer&#8217;s website.<\/p>\n<p>Look for the reason for the recall. It&#8217;s possible that the product only poses a danger to pregnant women, immunocompromised patients, or some other narrow segment of the population.<\/p>\n<p>Call your doctor to determine whether you should keep taking the drug or need a new prescription if there is a <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/dangerous-drugs.html\">drug recall<\/a>.<\/p>\n<p>If you determine the product may be dangerous, stop using it. If the product is non-perishable, like pills or cosmetics, keep the product in a safe place. Don&#8217;t throw it out. Your personal injury lawyer may need it in\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/case-preparation-issues.html\">preparation for your case<\/a>.<\/p>\n<h3>What To Do After a Food Recall<\/h3>\n<p>It&#8217;s common for the FDA to recall food products. You will often hear news stories about the FDA recalling lettuce or some other type of produce. There are also frequent recalls of <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/foods-most-associated-with-food-poisoning.html\">meat and poultry<\/a>.<\/p>\n<p>If the FDA or a company\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/food-recalls.html\">recalls food<\/a>, throw it out. It doesn&#8217;t matter how much it costs; no food is worth keeping if it can harm you. Save your receipts and labels. You&#8217;ll need them as evidence later.<\/p>\n<p>Once you discard the food, employ <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/food-poisoning-prevention-basics.html\">food safety techniques<\/a> to prevent other foodborne illnesses from spreading.<\/p>\n<p>Throw out any utensils that came into contact with the recalled food. Thoroughly clean and disinfect countertops and other surfaces that touched the recalled food. Failing to do this can create a health hazard because it may cause cross-contamination.<\/p>\n<h2>Is a Recall Evidence of a Company&#8217;s Liability?<\/h2>\n<p>Some manufacturers don&#8217;t recall dangerous products because they don&#8217;t want legal action filed against them. They fear consumers <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/get-legal-help-with-a-defective-product-injury.html\">will sue them<\/a> for damages if they recall a product.<\/p>\n<p>While it may help to submit evidence of a recall, your <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a> must still prove your case. Just because a product is subject to a recall doesn&#8217;t mean it&#8217;s unsafe overall. You must demonstrate you suffered adverse health consequences to collect damages.<\/p>\n<p>Your lawyer will consider the details of the recall, including:<\/p>\n<ul>\n<li>Which products were affected<\/li>\n<li>The danger involved<\/li>\n<li>The degree of risk<\/li>\n<\/ul>\n<p>Remember that if a company issues a recall but you <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/get-legal-help-with-a-car-or-vehicle-defect-or-recall.html\">don&#8217;t replace or repair it<\/a>, it can hurt your case. The defendant will argue that you wouldn&#8217;t have gotten hurt had you followed up on the recall.<\/p>\n<h2>Learn More About Product Recalls From an Attorney<\/h2>\n<p>If you&#8217;re hurt while using a recalled product, you may have a\u00a0<a href=\"https:\/\/dictionary.findlaw.com\/definition\/cause-of-action.html\" target=\"_blank\" rel=\"noopener\">cause of action<\/a>\u00a0against the manufacturer, distributor, retailer, or anyone in the distribution chain. Your attorney will demand compensation for your medical expenses, lost wages, and pain and suffering.<\/p>\n<p>Contact a skilled\u00a0<a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a>\u00a0in your area to learn whether you have a viable product liability claim.<\/p>\n\n\n<div class=\"was-this-helpful\">\n    <div\n            class=\"was-this-helpful__question-container\"\n            aria-labelledby=\"was-this-helpful__question\"\n            role=\"group\"\n    >\n        <span\n                id=\"was-this-helpful__question\"\n                class=\"was-this-helpful__question fl-text-lg-bold\"\n        >Was this helpful?<\/span>\n        <button\n                class=\"was-this-helpful__button fl-text-sm\"\n                aria-label=\"Yes\"\n                value=\"yes\"\n        >\n            <span class=\"was-this-helpful__button-text fl-text-bold\">Yes<\/span>\n            <i 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data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    Accident and injury claims are complex and insurance carriers have teams of specialized attorneys\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    A lawyer can help gather evidence and documentation to support your claim\n\n                <\/li>\n                    <\/ul>\n                    <div class=\"fl-editors-summary-content-description\" data-testid=\"fl-editors-summary-content-description\">\n                <p>An attorney can increase your chances of success with your case. Many attorneys offer free consultations.<\/p>\n\n            <\/div>\n                            <div class=\"fl-editors-summary-content-link fl-flex\" data-testid=\"fl-editors-summary-content-link\">\n                <i class=\"fa fa-angle-right medium\" aria-hidden=\"true\"><\/i>\n                <p class=\"find-attorney\"><a href=\"https:\/\/lawyers.findlaw.com\/personal-injury-plaintiff\/#USER_GEO\/?fli=esum:FL3905\" target=\"_blank\" rel=\"noopener\">Find a local attorney<\/a><\/p>\n\n            <\/div>\n            <\/div>\n<\/div>\n\n\n\n<div class=\"email-subscription fl-mb30\">\n    <div class=\"email-subscription-header\">\n        <div class=\"email-subscription-header-content\">\n            <h3 class=\"fl-callout-sm fl-no-margin\">Stay Up-to-Date With How the Law Affects Your Life<\/h3>\n        <\/div>\n        <div class=\"email-subscription-header-image fl-flex fl-items-end\">\n            <img decoding=\"async\"\n                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Injury Lawyers<\/a><\/li>\n                            <\/ul>\n        <\/div>\n    <\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm&#8217;s own initiative, by FDA request, or by FDA order under.  Learn more at Findlaw.com.<\/p>\n","protected":false},"author":41135,"featured_media":0,"parent":353191,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"app\/Http\/Controllers\/Templates\/ArticleWithBreadcrumbsController.php","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_autodraft_ids":[],"_cloudinary_featured_overwrite":false,"_sb_is_suggestion_mode":false,"_sb_show_suggestion_boards":false,"_sb_show_comment_boards":false,"_sb_suggestion_history":"","_sb_update_block_changes":"","_is_real_time_mode":false,"_realtime_collaborators":"","footnotes":"","cf_checklist_status":[]},"categories":[2734],"tags":[],"state_laws_tags":[],"flmsa":[],"class_list":["post-353260","page","type-page","status-publish","hentry","category-injury"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages\/353260","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/users\/41135"}],"replies":[{"embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/comments?post=353260"}],"version-history":[{"count":0,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages\/353260\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/pages\/353191"}],"wp:attachment":[{"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/media?parent=353260"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/categories?post=353260"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/tags?post=353260"},{"taxonomy":"state_laws_tags","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/state_laws_tags?post=353260"},{"taxonomy":"flmsa","embeddable":true,"href":"https:\/\/www.findlaw.com\/law-api\/wp-json\/wp\/v2\/flmsa?post=353260"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}