Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Corlanor (ivabradine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDCs
55513-0800-60
55513-0800-99
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Corlanor ivabradine NDC 55513-0800 |
HYDROCHLORIDE 5 mg/1 | Tablet, Film Coated Oral |
Amgen Inc | Rx |
- Recalling firm
- Amgen, Inc.
- NDC code
- 55513-800-99
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0612-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Amgen, Inc.
All 2026 recalls
Class II · Moderate risk
Corlanor (ivabradine)
Presence of Foreign Substance.
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Other particulate / foreign matter recalls from 2026
All particulate / foreign matter recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
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