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Drug Recalls | FDA

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Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm\u0027s own initiative, by FDA request, or by FDA order under statutory authority.", "datePublished": "Fri, 09/29/2023 - 12:38", "dateModified": "Fri, 09/29/2023 - 11:21", "author": { "@type": "Organization", "name": "Center for Drug Evaluation and Research" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls" /> <link rel="canonical" href="https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls" /> <link rel="shortlink" href="https://www.fda.gov/node/360953" /> <link rel="alternate" type="application/vnd.openxmlformats-officedocument.spreadsheetml.sheet" title="CDER Data Export " href="http://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls/download?page&amp;_format=xlsx" /> <script src="/files/google_tag/production/google_tag.script.js?smjbjq" defer></script> <title>Drug Recalls | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_d_MWYqVDKbn7kUma8CZF28_CX3CAHWeEg54sDHGteEo.css?delta=0&amp;language=en&amp;theme=preview&amp;include=eJx1kF1uxCAMhC9EQl9W6m2QASehBYywk9309M1Pm2wb7QsaPht7mI6ywB2ZEuru1K3qifqIBjLEWYJj_R8onlkwaQuMqlScAt51H8lCbFjmGHJ_wa6GIqwskbBUKLpQoQmr6jwY94k-CFWDeYDsMGEW1uAcVR8oG6F-NcADVXHkUa2jWW9nm8iPEfc5lEoM64S9Zm5v70_wzzP4gIfqFjuZBFkf6nDuKnzN2J9f8VC25b_3w05zON03GA8CBh9lqesLUasWsHHZesrmSOZVfRShzM0gKd5e9HjsYIzSVOSy9IbpNLvE0zx1rmyLbEk6yGxspTtj1Vek3ECMWfs6FojtfvuBJgard9k65m-SNeno" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&amp;language=en&amp;theme=preview&amp;include=eJx1kF1uxCAMhC9EQl9W6m2QASehBYywk9309M1Pm2wb7QsaPht7mI6ywB2ZEuru1K3qifqIBjLEWYJj_R8onlkwaQuMqlScAt51H8lCbFjmGHJ_wa6GIqwskbBUKLpQoQmr6jwY94k-CFWDeYDsMGEW1uAcVR8oG6F-NcADVXHkUa2jWW9nm8iPEfc5lEoM64S9Zm5v70_wzzP4gIfqFjuZBFkf6nDuKnzN2J9f8VC25b_3w05zON03GA8CBh9lqesLUasWsHHZesrmSOZVfRShzM0gKd5e9HjsYIzSVOSy9IbpNLvE0zx1rmyLbEk6yGxspTtj1Vek3ECMWfs6FojtfvuBJgard9k65m-SNeno" /> <script src="https://script.crazyegg.com/pages/scripts/0024/3700.js" async></script> <script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&amp;subagency=FDA&amp;sdor=fda.gov&amp;dclink=true" language="javascript" id="_fed_an_ua_tag"></script> <script>window.dataLayer = window.dataLayer || [];function gtag(){dataLayer.push(arguments)};gtag("js", new Date());gtag("set", "developer_id.dMDhkMT", true);gtag("config", "G-273DTKB5QW", {"groups":"default","page_placeholder":"PLACEHOLDER_page_location","allow_ad_personalization_signals":false});</script> </head> <body class="role-anonymous path-node page-node-type-sub-section has-glyphicons"> <div id="quicklinks" class="sr-only"> <ul> <li><a href="#main-content" class="sr-only sr-only-focusable" tabindex="1">Skip to main content</a></li> <li><a href="#search-form" class="sr-only sr-only-focusable" tabindex="1">Skip to FDA Search</a></li> <li><a href="#section-nav" class="sr-only sr-only-focusable" tabindex="1">Skip to in this section menu</a></li> <li><a href="#footer-heading" class="sr-only sr-only-focusable" tabindex="1">Skip to footer links</a></li> </ul> </div> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M95XGZW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="main-container container-fluid"> <div class="row"> <header class="lcds-header container-fluid" role="heading" aria-level="1"> <div class="row us-masthead"> <div class="usa-banner col-xs-12"> <img class="usa-banner__us-flag" src="/themes/custom/preview/assets/images/US_Flag.png" alt="U.S. flag" /> <span>An official website of the United States government</span> <a id="USMenuButton" class="collapsed" data-toggle="collapse" data-target="#USABannerMenu" aria-controls="USABannerMenu">Here’s how you know <span class="toggle-indicator"> </span></a> <div class="col-xs-12 collapse usa-banner__menu" id="USABannerMenu" aria-labelledby="USMenuButton"> <div id="gov-banner" class="row usa-banner-content usa-grid usa-accordion-content" aria-hidden="true"> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-dot-gov.svg" alt="Dot gov" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The .gov means it’s official.</strong><br>Federal government websites often end in .gov or .mil. 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href="/drugs/drug-safety-and-availability" title="Drug Safety and Availability"> Drug Safety and Availability </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">Drug 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%2Fdrugs%2Fdrug-safety-and-availability%2Fdrug-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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lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <p>A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market or warn patients and consumers about a potential risk.</p> <p>The list below includes voluntary drug recalls in which public notification has been issued.</p> <p>Visit&nbsp;<a href="/drugs/drug-recalls/fdas-role-drug-recalls" target>FDA’s role in drug recalls</a> for more information.<br> Visit&nbsp;<a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4c560ad3-a233-4d73-8973-492ad9d2b6ae" href="/safety/recalls-market-withdrawals-safety-alerts" title="Recalls, Market Withdrawals, &amp; Safety Alerts">Recalls, Market Withdrawals, &amp; Safety Alerts</a>&nbsp;for all FDA-regulated products.<br> Follow FDA Recall Information on <a href="https://twitter.com/fdarecalls">X</a> (formerly Twitter).</p> <br> <br> <section class="views-element-container block block-views block-views-blockrecall-solr-index-cder-recall-datatable-block-1 clearfix" id="block-views-block-recall-solr-index-cder-recall-datatable-block-1" data-block-plugin-id="views_block:recall_solr_index-cder_recall_datatable_block_1"> <div class="form-group"><div class="view view-recall-solr-index view-id-recall_solr_index view-display-id-cder_recall_datatable_block_1 js-view-dom-id-6e1697838c677f493e0cee7c70bd05348212be7ec263150aeedcfb2ea6a649eb"> <div class="view-filters form-group"> <div class="views-exposed-form datatables-exposed-form" data-drupal-selector="views-exposed-form-recall-solr-index-cder-recall-datatable-block-1" action="#" method="get" id="views-exposed-form-recall-solr-index-cder-recall-datatable-block-1" accept-charset="UTF-8"> <form class="datatable-exposed-form"> <div class="views-exposed-form lcds-datatable-filter" data-drupal-selector="views-exposed-form-recall-solr-index-cder-recall-datatable-block-1"> <div class="form-item js-form-item form-type-textfield js-form-type-textfield form-item-search-api-fulltext js-form-item-search-api-fulltext form-group"> <label for="edit-search-api-fulltext" class="control-label">Search</label> <input data-drupal-selector="edit-search-api-fulltext" class="form-text form-control" type="text" id="edit-search-api-fulltext" name="search_api_fulltext" value="" /> </div> <div class="panel-group" id="accordion"> <div class="panel panel-default"> <div class="panel-heading"> <h2 class="panel-title"> <a data-toggle="collapse" data-parent="#accordion" href="#collapseOne" class="toggle">Filter by</a> </h2> </div> <div id="collapseOne" class="panel-collapse collapse in"> <div class="panel-body"> <div class="row"> <div class="col-sm-12 lcds-datatable-filter__group"> <div class="form-group"> <div class="col-sm-12 lcds-datatable-filter__group"> <div class="form-item js-form-item form-type-select js-form-type-select form-item-field-terminated-recall js-form-item-field-terminated-recall form-group"> <label for="edit-field-terminated-recall" class="control-label">Terminated Recall</label> <span class="select-wrapper"><select data-drupal-selector="edit-field-terminated-recall" class="form-select form-control" id="edit-field-terminated-recall" name="field_terminated_recall"><option value="All" selected="selected">- Any -</option><option value="1">Yes</option><option value="0">No</option></select></span> </div> </div> </div> </div> </div> <div class="col-sm-12"> <p class="lcds-explainer-txt">A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.</p> </div> <input id="datatable-reset" type="reset" class='btn btn-default float-right' value="Clear Filters" /> </div> </div> </div> </div> </div> </form> </div> </div> <div class="view-content"> <table class="lcds-datatable table table-bordered cols-7" id="datatable"> <thead> <tr> <th id="view-field-change-date-2-table-column" aria-sort="descending" class="views-field views-field-field-change-date-2 is-active" scope="col">Date </th> <th id="view-brand-name-table-column" class="views-field views-field-brand-name" scope="col">Brand Name(s) </th> <th id="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1" scope="col">Product Description </th> <th id="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1" scope="col">Recall Reason Description</th> <th id="view-company-name-table-column" class="views-field views-field-company-name" scope="col">Company Name </th> <th id="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall" scope="col">Terminated Recall</th> <th class="all views-field views-field-search-api-excerpt" id="view-search-api-excerpt-table-column" scope="col">Excerpt</th> </tr> </thead> <tbody> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-21T17:00:00Z">11/21/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/mxbbb-issues-voluntary-nationwide-recall-umary-acid-hyaluronic-due-presence-diclofenac-and">Umary</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">UMARY Hyaluronic Acid tablets </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">The product contains undeclared diclofenac and omeprazole </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">MXBBB </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T17:00:00Z">11/19/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/endo-expands-voluntary-recall-clonazepam-orally-disintegrating-tablets-usp-c-iv-due-potential">Par Pharmaceutical</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">Clonazepam Orally Disintegrating Tablets, USP (C-IV) </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Mislabeled with the incorrect strength on the carton </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">Endo, Inc. </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-06T05:00:00Z">11/06/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/vitalityvita-issues-voluntary-nationwide-recall-vitalityxtra-and-peakmax-capsules-due-presence">VitalityVita</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">Marketed as Dietary Supplement </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Undeclared Sildenafil and Diclofenac </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">VitalityVita </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-05T05:00:00Z">11/05/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/boulla-llc-issues-voluntary-nationwide-recall-zoommax-and-zapmax-capsules-due-presence-undeclared">Boulla LLC</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">Marketed as Dietary Supplement </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Undeclared Sildenafil and Diclofenac </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">Boulla LLC </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-10-16T04:00:00Z">10/16/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/ca-naturistics-issues-voluntary-nationwide-recall-ak-forte-tablets-con-ortiga-y-omega-3-due-presence">AK Forte</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">AK Forte Dietary Supplement </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Device &amp; Drug Safety – Unapproved Drug </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">C&amp;A Naturistics </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-10-16T04:00:00Z">10/16/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/staska-pharmaceuticals-inc-issues-voluntary-nationwide-recall-ascorbic-acid-solution-injection">STASKA Pharmaceuticals</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">Ascorbic Acid Solution for Injection </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Device &amp; Drug Safety – Presence of glass particulates </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">STASKA Pharmaceuticals Inc. </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-09-23T04:00:00Z">09/23/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/gilead-issues-voluntary-nationwide-recall-one-lot-veklury-remdesivir-injection-100-mgvial-due">Gilead</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1"> Veklury (remdesivir) for Injection </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Due to Presence of Glass Particle </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">Gilead Sciences, Inc. </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-09-20T04:00:00Z">09/20/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/123herbals-llc-123herbalscom-issues-voluntary-nationwide-recall-vail-bon-jie-yang-wan-capsules-due">Vail-Bon</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">Vail-Bon Jie Yang Wan </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Product is tainted with dexamethasone and chlorpheniramine </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">123herbals </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-09-18T04:00:00Z">09/18/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/bionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial">BionPharma</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">Atovaquone Oral Suspension, 750 mg/mL </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Product found to be contaminated with Cohnella bacteria </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">Bionpharma Inc. </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-08-24T04:00:00Z">08/24/2024</time> </td> <td headers="view-brand-name-table-column" class="views-field views-field-brand-name"><a href="/safety/recalls-market-withdrawals-safety-alerts/sierra-stain-recalls-tattoo-pigments-because-possible-health-risk">Bloodline</a> </td> <td headers="view-field-product-description-1-table-column" class="views-field views-field-field-product-description-1">Water Based Tattoo Pigments </td> <td headers="view-field-recall-reason-description-1-table-column" class="views-field views-field-field-recall-reason-description-1">Contaminated with high concentrations of microorganisms </td> <td headers="view-company-name-table-column" class="views-field views-field-company-name">Sierra Stain LLC </td> <td headers="view-field-terminated-recall-table-column" class="views-field views-field-field-terminated-recall"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> </tbody> 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