Amgen is pulling nearly a million bottles of two widely used prescription drugs after routine quality checks at its Thousand Oaks manufacturing campus turned up an unwelcome surprise on some tablets: foreign material stuck to the outside of the pills. The voluntary recall covers certain lots of Corlanor, a heart medication, and Sensipar, commonly used in chronic kidney disease, that were processed in a specific packaging area on the company’s campus. Regulators and the company say the immediate clinical risk appears low, but pharmacies and prescribers have already been alerted.
According to the California State Board of Pharmacy, Amgen launched the recall after what it described as a “low frequency event” in which foreign matter was discovered on a reserve sample. The board noted that “the unexpected foreign matter was localized on the exterior tablet surface, over the coating,” and said Amgen is recalling lots that went through its AML Building 23 packaging area. A hazard assessment cited in the alert concluded that the overall risk to patients is low, and regulators say there have been no related complaints so far.
Fox Business reports that at least 944,142 bottles in the United States are affected. The U.S. Food and Drug Administration has tagged the move as a Class II recall, a category that, under agency guidance, covers products where use or exposure “may cause temporary or medically reversible adverse health consequences” or where the chance of serious harm is considered remote, according to the FDA.
Which lots and dates are affected
The recall spans multiple presentations of Corlanor, including 5 mg tablets in both 60-count and 14-count bottles (NDCs 55513-800-60 and 55513-800-99), along with related 60-count packs, as well as Sensipar tablets in 30 mg, 60 mg, and 90 mg strengths (NDCs 55513-073-30, 55513-074-30, and 55513-075-30). The affected lots were distributed from October 28, 2021, through December 30, 2025, according to the lot table in the California State Board of Pharmacy notice. Pharmacists and wholesalers are being urged to comb through their shelves and inventories against the full lot listing provided in that board alert.
What patients should do
Patients taking Corlanor or Sensipar are advised to check the National Drug Code (NDC) and lot number on their prescription label against the recall list, but to keep taking their medication unless their clinician tells them otherwise. Consumer guidance from AARP recommends calling your pharmacy or prescriber for instructions on next steps rather than abruptly stopping treatment on your own.
The Sensipar prescribing information on DailyMed notes that patients and providers can reach Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) and includes FDA MedWatch reporting instructions for any suspected adverse reactions.
Why this matters
Corlanor (ivabradine) is used in certain patients with chronic heart failure, and Sensipar (cinacalcet) helps control parathyroid hormone levels in people with advanced kidney disease. In other words, these are not casual prescriptions, and any recall, even a precautionary one, can create confusion and stress for patients who depend on them.
Health providers say this recall appears to be primarily a safety-first move, noting that the state board’s hazard assessment put the patient risk in the low category and that no complaints have surfaced so far. Even so, patients are being urged to confirm whether their specific bottle is included in the affected lots and to talk with their clinicians about replacements or alternatives if needed. For official product labeling and safety contact details, patients and providers can consult the Corlanor and Sensipar prescribing information available through the FDA and DailyMed sites.
