{"id":253854,"date":"2025-10-27T03:43:19","date_gmt":"2025-10-27T03:43:19","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/253854\/"},"modified":"2025-10-27T03:43:19","modified_gmt":"2025-10-27T03:43:19","slug":"cholesterol-medication-recalled-over-failed-dissolution-specifications-what-to-know","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/253854\/","title":{"rendered":"Cholesterol medication recalled over \u2018failed dissolution specifications\u2019: What to know"},"content":{"rendered":"<p class=\"mb-4 text-lg md:leading-8 break-words\">(NEXSTAR) \u2013 Over 141,000 bottles of cholesterol medication have been recalled due to \u201cfailed dissolution specifications,\u201d suggesting that the drugs did not pass a solubility test, or <a href=\"https:\/\/www.fda.gov\/media\/70936\/download\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:failed to dissolve at a standard rate.;elm:context_link;itc:0;sec:content-canvas\" class=\"link \">failed to dissolve at a standard rate.<\/a><\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">Ascend Laboratories, LLC, a New Jersey-based pharmaceutical company, first initiated its recall of the atorvastatin calcium tablets on Sept. 19, 2025, according to an <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/ires\/?Event=97639\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:enforcement report;elm:context_link;itc:0;sec:content-canvas\" class=\"link \">enforcement report<\/a> from the U.S. Food and Drug Administration.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">This month, the recalled drugs were categorized under <a href=\"https:\/\/www.fda.gov\/safety\/industry-guidance-recalls\/recalls-background-and-definitions\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:a \u201cClass II\u201d recall,;elm:context_link;itc:0;sec:content-canvas\" class=\"link \">a \u201cClass II\u201d recall,<\/a> meaning health officials believe the use of the recalled product \u201cmay cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,\u201d according to the FDA.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\"><a class=\"link \" href=\"https:\/\/thehill.com\/homenews\/nexstar_media_wire\/5561067-what-happens-to-federal-employees-who-violate-the-hatch-act\/?ipid=promo-link-block1\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:What happens to federal employees who violate the Hatch Act?;elm:context_link;itc:0;sec:content-canvas\"> What happens to federal employees who violate the Hatch Act? <\/a><\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">The recall currently only affects bottles of 10mg, 20mg, 40mg and 80mg atorvastatin calcium tablets manufactured by Alkem Laboratories, Ltd., of India, and distributed by Ascend. The recalled bottles contained different quantities of the tablets, ranging from 90-count to 1000-count bottles. Just under 142,000 bottles of the 10mg medication were involved in the recall; the quantity of recalled bottles containing 20mg, 40mg and 80mg tablets was listed in the FDA\u2019s enforcement report.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">More specific information on the recalled medication, including lot codes and expiration dates, is available <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/ires\/?Event=97639\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:in the report.;elm:context_link;itc:0;sec:content-canvas\" class=\"link \">in the report.<\/a><\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">A representative for Ascend Laboratories, LLC, was not immediately available to comment or to provide information for consumers who have any of the recalled medication in their possession. The FDA urges speaking with a doctor or pharmacist, but explains that \u201cconsumers can generally continue taking the medicine unless the recalling company provides other instructions.\u201d<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">\u201cIn some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine,\u201d <a href=\"https:\/\/www.fda.gov\/drugs\/drug-recalls\/drug-recall-information-consumers-health-care-professionals-and-industry\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:the FDA says.;elm:context_link;itc:0;sec:content-canvas\" class=\"link \">the FDA says.<\/a><\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">Atorvastatin calcium is a drug used to <a href=\"https:\/\/medlineplus.gov\/druginfo\/meds\/a600045.html\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:control cholesterol levels;elm:context_link;itc:0;sec:content-canvas\" class=\"link \">control cholesterol levels<\/a> and help prevent heart attacks or strokes, per the National Institutes of Health. The most common brand name of atorvastatin calcium tablets is Lipitor, a drug manufactured by Pfizer. In 2023, <a href=\"https:\/\/www.health.harvard.edu\/heart-health\/statins-types-uses-side-effects-and-alternatives\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:Harvard Health;elm:context_link;itc:0;sec:content-canvas\" class=\"link \">Harvard Health<\/a> estimated that more than 40 million Americans are prescribed statins, making them \u201cthe most prescribed\u201d drug in the country.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\"><a href=\"https:\/\/thehill.com\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:For the latest news, weather, sports, and streaming video, head to The Hill.;elm:context_link;itc:0;sec:content-canvas\" class=\"link \"> For the latest news, weather, sports, and streaming video, head to The Hill. <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"(NEXSTAR) \u2013 Over 141,000 bottles of cholesterol medication have been recalled due to \u201cfailed dissolution specifications,\u201d suggesting that&hellip;\n","protected":false},"author":2,"featured_media":253855,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[54859,134194,137902,10474,97,252,253,9553,47154,243,66969,137903,137904],"class_list":["post-253854","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health-care","tag-alkem-laboratories","tag-atorvastatin-calcium-tablets","tag-enforcement-report","tag-food-and-drug-administration","tag-health","tag-health-care","tag-healthcare","tag-laboratories","tag-llc","tag-medication","tag-pharmaceutical-company","tag-recalled-drugs","tag-recalled-product"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/253854","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=253854"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/253854\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/253855"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=253854"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=253854"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=253854"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}