Amgen Recalls Corlanor Tablets Over Foreign Substance
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Amgen Inc. is voluntarily recalling 934,577 bottles of Corlanor (ivabradine) 5 mg tablets due to the presence of a foreign substance. The Class II recall affects specific lots distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Amgen, Inc. initiated a voluntary recall of Corlanor (ivabradine) tablets after discovering the presence of a foreign substance.
Which Products Are Affected
Corlanor (ivabradine) tablets, 5 mg, packaged in 14-tablet bottles (NDC 55513-800-99) and 60-tablet bottles (NDC 55513-800-60). Affected lots include 1138901 (exp. 08/31/2026), 1149846 (exp. 04/30/2027), 1138201, 1138202 (exp. 08/31/2026), and numerous additional lots with expiration dates through 10/31/2028. A total of 934,577 bottles are involved. The products are manufactured by Amgen Inc., Thousand Oaks, CA, and distributed nationwide.
What You Should Do
Consumers should contact their healthcare provider or pharmacist regarding the recalled product. The recall was initiated by letter.
Why This Matters
This ongoing Class II recall involves a prescription drug distributed across the United States, with potential for temporary or reversible adverse health consequences.
Source
FDA recall number D-0612-2026; Amgen, Inc., Thousand Oaks, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,040 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.