Corlanor (ivabradine) tablets recall
FDA recall D-0615-2026 · initiated Jun 4, 2026
Amgen, Inc. recalled Corlanor (ivabradine) tablets in Jun 2026 — an FDA Class II recall (D-0615-2026) 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: N/A
Details
- Product
- Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
- 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-0615-2026) 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-0615-2026 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 — Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028. 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-0615-2026.