{"id":606,"date":"2025-10-30T06:11:00","date_gmt":"2025-10-30T13:11:00","guid":{"rendered":"https:\/\/getasecondopinion.ai\/blog\/?p=606"},"modified":"2025-10-29T21:13:15","modified_gmt":"2025-10-30T04:13:15","slug":"fda-recalls-atorvastatin-calcium-after-failed-dissolution-testing","status":"publish","type":"post","link":"https:\/\/www.getasecondopinion.ai\/blog\/news\/fda-recalls-atorvastatin-calcium-after-failed-dissolution-testing\/","title":{"rendered":"FDA Recalls 141,984 Bottles of Atorvastatin Calcium After Failed Dissolution Testing"},"content":{"rendered":"\n<p>On 10 October 2025 the U.S. Food and Drug Administration (FDA) classified a nationwide recall of Atorvastatin Calcium tablets, initiated by Ascend Laboratories, LLC, as a <strong>Class II recall<\/strong> because multiple lots \u201cfailed dissolution specifications,\u201d affecting 141,984 bottles distributed across the United States. The recalled product is a generic formulation of atorvastatin (a statin widely used to reduce low\u2011density lipoprotein cholesterol and cardiovascular risk), manufactured by Alkem Laboratories, Ltd. (India) and distributed by Ascend Laboratories (Parsippany, NJ).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What the recall means&nbsp;<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Recall classification<\/strong>: Class II \u2014 the product \u201cmay cause temporary or medically reversible adverse health consequences\u201d while serious adverse outcomes are considered remote.<\/li>\n\n\n\n<li><strong>Root cause reported<\/strong>: Failure to meet dissolution specifications during quality testing. Dissolution testing assesses how quickly and completely a solid oral dosage form releases the active pharmaceutical ingredient under standardized in vitro conditions; failure may reduce systemic bioavailability and thus clinical effectiveness.<\/li>\n\n\n\n<li><strong>Scale<\/strong>: 141,984 bottles across multiple strengths (10 mg, 20 mg, 40 mg, 80 mg) and container sizes (90-, 500-, 1,000-count) with expiration dates ranging from mid\u20112026 to February 2027.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Affected products (concise table)<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Strength<\/strong><\/td><td><strong>Bottle sizes<\/strong><\/td><td><strong>Typical NDC prefix<\/strong><\/td><td><strong>Representative lot ranges<\/strong><\/td><td><strong>Expiration range<\/strong><\/td><\/tr><tr><td>10 mg<\/td><td>90, 500, 1,000 count<\/td><td>67877-511<\/td><td>Multiple lots (e.g., 25141249; 24144938)<\/td><td>July 2026\u2013Feb 2027<\/td><\/tr><tr><td>20 mg<\/td><td>90, 500, 1,000 count<\/td><td>67877-512<\/td><td>Multiple lots (e.g., 25140150; 24144720)<\/td><td>June 2026\u2013Dec 2026<\/td><\/tr><tr><td>40 mg<\/td><td>90, 500, 1,000 count<\/td><td>67877-513<\/td><td>Multiple lots (e.g., 25140933; 24144254)<\/td><td>Sep 2026\u2013Feb 2027<\/td><\/tr><tr><td>80 mg<\/td><td>90, 500 count<\/td><td>67877-514<\/td><td>Multiple lots (e.g., 25140249; 24144999)<\/td><td>Aug 2026\u2013Dec 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Source: <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/ires\/?Event=97639.\">FDA enforcement report<\/a>.<\/p>\n\n\n\n<div class=\"wp-block-group unauthenticated invisible has-global-padding is-layout-constrained wp-container-core-group-is-layout-675f737c wp-block-group-is-layout-constrained\" style=\"padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<div class=\"wp-block-group cta-background has-background has-global-padding is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-64f51f8a wp-block-group-is-layout-constrained\" style=\"border-style:none;border-width:0px;border-radius:30px;background-color:#f6fffc;padding-top:var(--wp--preset--spacing--30);padding-right:var(--wp--preset--spacing--30);padding-bottom:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);box-shadow:var(--wp--preset--shadow--natural);background-image:url(&apos;https:\/\/getasecondopinion.ai\/blog\/wp-content\/uploads\/2025\/10\/cta-background-03b.webp&apos;);background-position:100% 100%;background-repeat:no-repeat;background-size:contain;background-attachment:scroll;\">\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-153751c2 wp-block-group-is-layout-constrained\" style=\"padding-bottom:10px\">\n<h3 class=\"wp-block-heading has-text-align-center has-accent-1-color has-text-color has-link-color has-large-font-size wp-elements-9363713a6feba58457096f3ce3e67f32\">Stop Overpaying for Meds.<\/h3>\n\n\n\n<p>Coupons aren\u2019t your only option &#8211; see if safer, more effective, and lower-cost alternatives are available. It\u2019s fast, personalized, and 100% free. <strong><a href=\"https:\/\/getasecondopinion.ai\/intro-summary\" target=\"_blank\" rel=\"noreferrer noopener\">Learn More \u2192<\/a><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Clinical and public\u2011health implications<\/strong><\/h3>\n\n\n\n<p>Atorvastatin is one of the most commonly prescribed statins in the U.S.; estimates indicate tens of millions of adults take statins for primary and secondary prevention of atherosclerotic cardiovascular disease. When a tablet fails dissolution testing, the principal concern is suboptimal absorption of the active drug in vivo, which can reduce LDL\u2011cholesterol lowering and attenuate the protective benefits against myocardial infarction and stroke over time if many doses are under\u2011delivering active drug.<\/p>\n\n\n\n<p>However, the FDA\u2019s Class II designation and standard regulatory guidance indicate that while the dissolution failure represents a significant quality issue, the likelihood of acute, severe toxicity is low; the primary risk is reduced efficacy rather than direct harm from an impurity or contamination event. Clinical management should therefore focus on ensuring continued lipid control rather than immediate emergency interventions for asymptomatic patients.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Recommended actions for patients and clinicians<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Check medication labels<\/strong>: Compare the NDC, lot number, strength, and expiration date on any atorvastatin bottles with the affected lot lists published by the FDA.<\/li>\n\n\n\n<li><strong>Do not stop statin therapy without clinical advice<\/strong>: Stopping statins abruptly can increase short\u2011term cardiovascular risk in some patients; decisions should be individualized and made with the prescribing clinician.<\/li>\n\n\n\n<li><strong>Contact pharmacist or prescriber<\/strong>: If your bottle is on the affected list, contact your pharmacist or healthcare provider to obtain guidance on replacement supply or therapeutic substitution. Pharmacies often have access to non\u2011affected lots and generics from alternate manufacturers.<\/li>\n\n\n\n<li><strong>Report quality issues or adverse events<\/strong>: Use the FDA MedWatch reporting system to document any product quality issues or suspected treatment failures related to the recalled lots.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Recall History<\/strong><\/h3>\n\n\n\n<p>The recall was initiated by the distributor Ascend Laboratories on 19 September 2025 and appears to apply to lots manufactured overseas (Alkem Laboratories, India) and distributed nationwide by Ascend\/Ascend Laboratories, LLC. Media coverage and health outlets have summarized the FDA enforcement report and advised consumers to verify lot numbers and consult clinicians or pharmacists for next steps. As of the FDA entry, Ascend had not issued a separate press release; the FDA enforcement report remains the primary authoritative source of lot and product detail.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What to watch next<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Replacement lots and supply management<\/strong>: Pharmacies and health systems will need to confirm inventory and source unaffected atorvastatin supplies to avoid lapses in therapy for patients at high cardiovascular risk.<\/li>\n\n\n\n<li><strong>Regulatory follow\u2011up<\/strong>: The FDA may require corrective and preventive actions from the manufacturer, including investigation into manufacturing process controls, dissolution method validation, and potential root\u2011cause analysis and remediation. Class II recalls typically trigger follow\u2011up inspections and submission of remediation plans to the agency.<\/li>\n<\/ul>\n\n\n\n<p><strong>Clinical outcome surveillance<\/strong>: Clinicians and public\u2011health entities may monitor lipid control metrics or adverse cardiovascular events in populations who received recalled lots, particularly where large doses or long refill supplies (500\u20131,000 count bottles) were dispensed.<\/p>\n\n\n\n<div class=\"wp-block-group unauthenticated invisible has-global-padding is-layout-constrained wp-container-core-group-is-layout-675f737c wp-block-group-is-layout-constrained\" style=\"padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<div class=\"wp-block-group cta-background has-custom-off-white-background-color has-background has-global-padding is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-64f51f8a wp-block-group-is-layout-constrained\" style=\"border-style:none;border-width:0px;border-radius:30px;padding-top:var(--wp--preset--spacing--30);padding-right:var(--wp--preset--spacing--30);padding-bottom:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);box-shadow:var(--wp--preset--shadow--natural);background-image:url(&apos;https:\/\/getasecondopinion.ai\/blog\/wp-content\/uploads\/2025\/09\/cta-background-01.webp&apos;);background-position:100% 100%;background-repeat:no-repeat;background-size:contain;background-attachment:scroll;\">\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-153751c2 wp-block-group-is-layout-constrained\" style=\"padding-bottom:10px\">\n<h3 class=\"wp-block-heading has-text-align-center has-accent-1-color has-text-color has-link-color has-large-font-size wp-elements-b6fe6b9c1e90c3ca0e3d22a4a0e21d9e\">Better Treatment, Lower Cost &#8211; No Catch.<\/h3>\n\n\n\n<p>Find safer, more effective medications with fewer side effects &#8211; often for less money. It\u2019s fast, free, and personalized. <strong><a href=\"https:\/\/getasecondopinion.ai\/intro-summary\" target=\"_blank\" rel=\"noreferrer noopener\">Learn More \u2192<\/a><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On 10 October 2025 the U.S. Food and Drug Administration (FDA) classified a nationwide recall of Atorvastatin Calcium tablets, initiated by Ascend Laboratories, LLC, as a Class II recall because multiple lots \u201cfailed dissolution specifications,\u201d affecting 141,984 bottles distributed across the United States. The recalled product is a generic formulation of atorvastatin (a statin widely [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":608,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[275,270,272,278,276,277,271,262,274,273],"class_list":["post-606","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-ascend-laboratories","tag-atorvastatin","tag-atorvastatin-calcium","tag-cholesterol-medication","tag-dissolution-testing","tag-drug-recall","tag-fda-recall","tag-medication-safety","tag-pharmaceutical-recall","tag-statin-recall"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Recalls 141,984 Bottles of Atorvastatin Calcium After Failed Dissolution Testing - Get a Second Opinion<\/title>\n<meta name=\"description\" content=\"FDA 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