Corlanor (ivabradine) tablets recall
FDA recall D-0612-2026 · initiated Jun 4, 2026
Amgen, Inc. recalled Corlanor (ivabradine) tablets in Jun 2026 — an FDA Class II recall (D-0612-2026) because Presence of Foreign Substance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Substance.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 934577 bottles
Details
- Product
- Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.
- Recalling company
- Amgen Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jun 4, 2026
- FDA report date
- Jul 1, 2026
This recall is linked to a product we cover: Corlanor →
Frequently asked
- Was Corlanor (ivabradine) tablets recalled?
- Amgen, Inc. recalled Corlanor (ivabradine) tablets in Jun 2026 — an FDA Class II recall (D-0612-2026) because Presence of Foreign Substance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Corlanor (ivabradine) tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0612-2026 was: Presence of Foreign Substance.
- Is a recalled Corlanor (ivabradine) tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Corlanor (ivabradine) tablets are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — a) Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027 b) Lot #1138201, 1138202, 08/31/2026, 1138900, 1141143, Exp. Date 08/31/2026; 1140280, 1140281, 1142063, Exp. Date 10/31/2026; 1142062, 1142942, 1142943, Exp. Date 11/30/2026; 1144081, 1144104, Exp. Date 12/31/2026; 1146373, 1146374, Exp. Date 01/31/…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0612-2026.