Medication Recall Alert
FDA Recalls Nearly 1 Million Bottles of Kidney and Heart Medications Nationwide Due to Foreign Substance
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The FDA has recalled nearly 1 million bottles of two widely used prescription medications — Corlanor, a heart drug, and Sensipar, a kidney drug — made by Amgen Inc. Action News Jax reported the recall covers 944,142 bottles distributed across the United States from October 28, 2021 through December 30, 2025. The FDA classified this as a Class II recall, meaning the risk of serious harm is low but not zero.
The trigger was "unexpected foreign matter" found on the surface of tablets during routine quality testing. Amgen said no illnesses or injuries have been reported. Still, patients with heart failure and chronic kidney disease who rely on these drugs now face uncertainty about whether their supply is safe.
Foreign Material on Tablets Sparked the Massive Recall
Amgen's internal quality team found a foreign substance on the outer coating of tablets — not inside the tablet itself — during a routine check of a reserve sample. The California State Board of Pharmacy identified the source as "AML Building 23" at Amgen's Thousand Oaks campus. Because the contamination was on the exterior surface, the active drug ingredients are believed to be unaffected, according to KIRO 7.
Beyond the foreign matter, the FDA also cited "CGMP deviations" — meaning Amgen's factory fell short of federal manufacturing standards. An Amgen spokesperson told media the recall is "a precautionary measure." The company officially started the recall on June 4, 2026. The FDA formally classified it on June 23, 2026.
Which Drugs Are Affected and Who Takes Them
Corlanor (ivabradine) is prescribed to reduce hospitalization risk in patients with chronic heart failure. Sensipar (cinacalcet) treats a condition called secondary hyperparathyroidism in kidney disease patients on dialysis. Both drugs manage serious, ongoing conditions — meaning patients cannot simply stop taking them without a doctor's guidance, according to WSBTV.
The recall covers multiple doses and package sizes. Corlanor comes in 5 mg and 7.5 mg tablets. Sensipar comes in 30 mg, 60 mg, and 90 mg strengths. Patients can check the NDC number and lot number printed on their bottle to see if their supply is included in the recall.
What Patients Should Do — and What Not to Do
The FDA is urging patients not to stop taking their medication without first talking to their doctor. Stopping heart failure or kidney disease drugs suddenly can be far more dangerous than the "remote" risk posed by a Class II manufacturing defect. Major pharmacies including CVS, Walgreens, and Rite Aid are contacting patients who received the affected lots, according to Boston 25 News.
Patients who have an affected bottle should contact their pharmacy for a replacement. This recall applies only to Amgen-branded Corlanor and Sensipar. It does not cover generic versions of ivabradine or cinacalcet. As of late June 2026, Amgen reported zero complaints of illness or injury tied to the recalled bottles.
Amgen Stock Holds Steady Despite Scale of Recall
Despite recalling nearly a million bottles, Amgen's stock showed little damage. Shares of AMGN traded at $358.33, up 1.56%, on June 28, 2026. Investors appeared to view the voluntary nature of the recall as a sign of strong internal oversight rather than a deeper problem, according to WPXI.
Still, Amgen faces other pressures. The company is dealing with a separate IRS tax dispute and the FDA's recent withdrawal of another Amgen drug, Tavneos. Critics have also questioned why it took from June 4 — when the recall began internally — until late June for the public to be widely notified. The FDA may review Amgen's Thousand Oaks facility further if the manufacturing problems are found to be widespread.
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