{"id":765774,"date":"2026-06-28T13:16:12","date_gmt":"2026-06-28T13:16:12","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/765774\/"},"modified":"2026-06-28T13:16:12","modified_gmt":"2026-06-28T13:16:12","slug":"nearly-1-million-bottles-of-heart-and-kidney-medication-recalled-fda","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/765774\/","title":{"rendered":"Nearly 1 million bottles of heart and kidney medication recalled: FDA"},"content":{"rendered":"\n<p>Kardigan co-founder and CEO Tassos Gianakakos discusses the new leads his company has found in battling heart disease on &#8216;The Claman Countdown.&#8217;<\/p>\n<p>Nearly one million bottles of heart and kidney medication have<a href=\"https:\/\/www.foxnews.com\/category\/health\/healthy-living\/product-recalls\" target=\"_blank\" rel=\"noopener nofollow\"> been recalled<\/a> nationwide over the possibility of a &#8220;foreign substance,&#8221; according to the U.S. Food and Drug Administration.<\/p>\n<p>California-based Amgen, Inc.\u00a0voluntarily recalled at least 944,142 bottles of Corlanor and Sensipar tablets after &#8220;unexpected foreign matter&#8221; was found &#8220;in the reserve sample of one of the identified lots,&#8221; the California state Board of Pharmacy said <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/ires\/?Event=99077\" target=\"_blank\" rel=\"noopener nofollow\">in an alert<\/a>.<\/p>\n<p>&#8220;The unexpected foreign matter was localized on the exterior tablet surface, over the coating,&#8221; the board said. &#8220;Therefore, as a precautionary measure, all lots within expiry that were processed in AML Building 23 packaging area, where the condition occurred, are being recalled.&#8221;<\/p>\n<p>The board added that hazard assessments have found it doesn\u2019t present a clinical risk to patients and &#8220;overall patient safety risk is low.&#8221;<\/p>\n<p><a href=\"https:\/\/www.foxnews.com\/health\/costco-brand-cold-flu-medication-recalled-fda-not-effective\" target=\"_blank\" rel=\"noopener nofollow\">COSTCO-BRAND COLD AND FLU MEDICATION RECALLED BY FDA: &#8216;NOT EFFECTIVE&#8217;<\/a><\/p>\n<p>    <img decoding=\"async\" src=\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/06\/Credible-prescription-cost-iStock-1190193494.jpg\" alt=\"pills\"\/> <\/p>\n<p>Nearly one million bottles of heart and kidney medication have been recalled nationwide. (iStock \/ iStock)<\/p>\n<p>There have been no complaints about the issue.<\/p>\n<p>Corlanor, which is also known by the generic name ivabradine, is prescribed to treat patients with chronic <a href=\"https:\/\/www.foxnews.com\/category\/health\/heart-health\" target=\"_blank\" rel=\"noopener nofollow\">heart failure<\/a> and Sensipar, also known as cinacalcet hydrochloride, is mainly used to treat overactive parathyroidism in chronic kidney disease patients.<\/p>\n<p>Ticker Security Last Change Change % <a href=\"https:\/\/www.foxbusiness.com\/quote?stockTicker=AMGN\" rel=\"nofollow noopener\" target=\"_blank\">AMGN<\/a> AMGEN INC. 358.33 +5.51<br \/>\n        +1.56%<\/p>\n<p>The tablets were distributed between Oct. 28, 2021 and Dec. 30, 2025.<\/p>\n<p>    <img decoding=\"async\" src=\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/06\/ampgen-headquarters.jpg\" alt=\"Amgen headquarters\"\/> <\/p>\n<p>Amgen&#8217;s headquarters in Thousand Oaks, Calif.\u00a0 (Paul Harris\/Getty Images, File \/ Getty Images)<\/p>\n<p><a href=\"https:\/\/www.foxnews.com\/health\/drug-approvals-2024-big-clinical-impact-according-goodrx\" target=\"_blank\" rel=\"noopener nofollow\">19 DRUG APPROVALS IN 2024 THAT HAD &#8216;BIG CLINICAL IMPACT,&#8217; ACCORDING TO GOODRX<\/a><\/p>\n<p>The recall includes the following presentations, according to the board:<\/p>\n<p>\u2022 Corlanor\u00ae (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-800-60<\/p>\n<p>\u2022 Corlanor\u00ae (ivabradine) 5 mg, 14 tablets in 1 bottle; NDC 55513-800-99<\/p>\n<p>\u2022 Corlanor\u00ae (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-810-60<\/p>\n<p>\u2022 Sensipar\u00ae (cinacalcet hydrochloride) 30 mg, 30 tablets in 1 bottle; NDC 55513-073- 30<\/p>\n<p>\u2022 Sensipar\u00ae (cinacalcet hydrochloride) 60 mg, 30 tablets in 1 bottle; NDC 55513-074- 30<\/p>\n<p>\u2022 Sensipar\u00ae (cinacalcet hydrochloride) 90 mg, 30 tablets in 1 bottle; NDC 55513-075- 30<\/p>\n<p>    <img decoding=\"async\" src=\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/06\/fda-hq.jpg\" alt=\"FDA HQ sign in Maryland\"\/> <\/p>\n<p>The FDA has characterized the medication recall as Class II. (Sarah Silbiger\/Getty Images, File \/ Getty Images)<\/p>\n<p><a href=\"https:\/\/foxnews.onelink.me\/xLDS?pid=AppArticleLink&amp;af_dp=foxnewsaf%3A%2F%2F&amp;af_web_dp=https%3A%2F%2Fwww.foxnews.com%2Fapps-products\" target=\"_blank\" rel=\"noopener nofollow\">CLICK HERE TO DOWNLOAD THE FOX NEWS APP<\/a><\/p>\n<p>The FDA has characterized the recall as Class II, meaning it could &#8220;cause temporary or medically reversible adverse health consequences or where the probability of <a href=\"https:\/\/www.foxnews.com\/food-drink\/dr-pepper-zero-sugar-recall-upgraded-fda-warns-serious-health-risk-diabetics\" target=\"_blank\" rel=\"noopener nofollow\">serious adverse health consequences<\/a> is remote.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"Kardigan co-founder and CEO Tassos Gianakakos discusses the new leads his company has found in battling heart disease&hellip;\n","protected":false},"author":2,"featured_media":765775,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[64,63,137,490],"class_list":["post-765774","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-au","tag-australia","tag-health","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/765774","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=765774"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/765774\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/765775"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=765774"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=765774"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=765774"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}