{"id":899711,"date":"2026-06-29T01:07:14","date_gmt":"2026-06-29T01:07:14","guid":{"rendered":"https:\/\/www.europesays.com\/us\/899711\/"},"modified":"2026-06-29T01:07:14","modified_gmt":"2026-06-29T01:07:14","slug":"nearly-1-million-bottles-of-heart-and-kidney-medication-recalled-over-foreign-substance-found-on-tablets","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/899711\/","title":{"rendered":"Nearly 1 million bottles of heart and kidney medication recalled over foreign substance found on tablets"},"content":{"rendered":"

Nearly one million bottles of heart and kidney medication <\/a>have\u00a0been recalled\u00a0nationwide over the possibility of a \u201cforeign substance,\u201d according to the US Food and Drug Administration.<\/p>\n

California-based Amgen, Inc.\u00a0voluntarily recalled at least 944,142 bottles of Corlanor and Sensipar tablets after \u201cunexpected foreign matter\u201d was found \u201cin the reserve sample of one of the identified lots,\u201d the California state Board of Pharmacy said\u00a0in an alert<\/a>.<\/p>\n

\u201cThe unexpected foreign matter was localized on the exterior tablet surface, over the coating,\u201d the board said. \u201cTherefore, as a precautionary measure, all lots within expiry that were processed in AML Building 23 packaging area, where the condition occurred, are being recalled.\u201d<\/p>\n

The board added that hazard assessments<\/a> <\/a>have found it doesn\u2019t present a clinical risk to patients and \u201coverall patient safety risk is low.\u201d<\/p>\n

There have been no complaints about the issue.<\/p>\n

\"ACalifornia-based Amgen, Inc. voluntarily recalled Corlanor and Sensipar due to \u201cunexpected foreign matter.\u201d rohane \u2013 stock.adobe.com<\/p>\n

Corlanor, which is also known by the generic name ivabradine, is prescribed to treat patients with chronic\u00a0heart failure\u00a0<\/a>and Sensipar, also known as cinacalcet hydrochloride, is mainly used to treat overactive parathyroidism in chronic kidney disease patients.<\/p>\n

The tablets were distributed between Oct. 28, 2021 and Dec. 30, 2025.<\/p>\n

The recall includes the following presentations, according to the board:<\/p>\n

\u2022 Corlanor\u00ae (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-800-60<\/p>\n

\u2022 Corlanor\u00ae (ivabradine) 5 mg, 14 tablets in 1 bottle; NDC 55513-800-99<\/p>\n

\u2022 Corlanor\u00ae (ivabradine) 5 mg, 60 tablets in 1 bottle; NDC 55513-810-60<\/p>\n

\u2022 Sensipar\u00ae (cinacalcet hydrochloride) 30 mg, 30 tablets in 1 bottle; NDC 55513-073- 30<\/p>\n

\u2022 Sensipar\u00ae (cinacalcet hydrochloride) 60 mg, 30 tablets in 1 bottle; NDC 55513-074- 30<\/p>\n

\u2022 Sensipar\u00ae (cinacalcet hydrochloride) 90 mg, 30 tablets in 1 bottle; NDC 55513-075- 30<\/p>\n

\"Close-upFDA classified the recall as Class II, noting a \u2018low\u2019 patient safety risk despite the foreign matter on tablet surfaces. Cultura Creative \u2013 stock.adobe.com<\/p>\n

The FDA has characterized the recall as Class II, meaning it could \u201ccause temporary or medically reversible adverse health consequences or where the probability of\u00a0serious adverse health consequences<\/a>\u00a0is remote.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Nearly one million bottles of heart and kidney medication have\u00a0been recalled\u00a0nationwide over the possibility of a \u201cforeign substance,\u201d…\n","protected":false},"author":3,"featured_media":899712,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[35],"tags":[151,210,1141,1142,4512,26417,298,1165,12310,67,132,68],"class_list":["post-899711","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health-care","tag-fda","tag-health","tag-health-care","tag-healthcare","tag-heart","tag-kidney","tag-kidney-disease","tag-lifestyle","tag-recalls","tag-united-states","tag-unitedstates","tag-us"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/116830723520692834","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/899711","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=899711"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/899711\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/899712"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=899711"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=899711"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=899711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}