Why it was recalled
Presence of Foreign Substance.
Product description
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0615-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 4, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amgen, Inc.
Original FDA data
Every field from FDA enforcement report D-0615-2026, exactly as published.
Show all FDA fields
- City
- Thousand Oaks
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 99077
- Address
- 1 Amgen Center Dr
- Code information
- 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
- Postal code
- 91320-1730
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0615-2026
- Classification
- Class II
- Recalling firm
- Amgen, Inc.
- Reason for recall
- Presence of Foreign Substance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 4, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2026