Corlanor ivabradine tablets recalled for presence of foreign substance
Amgen Inc. is recalling Corlanor (ivabradine) 5 mg tablets nationwide due to the presence of a foreign substance. The recall affects approximately 934,577 bottles distributed in the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source identifies this as an FDA Class II recall. The hazard is a foreign substance with no reported illnesses or injuries mentioned in the source text, making this a precautionary recall that meets the Moderate severity criterion.
Plain-English summary
Amgen Inc. is recalling Corlanor (ivabradine) 5 mg tablets due to the presence of a foreign substance. The affected product is packaged in 14-tablet bottles (NDC 55513-800-99) and 60-tablet bottles (NDC 55513-800-60), distributed nationwide within the United States.
Multiple lot numbers and expiration dates are affected, with lot numbers including 1138901, 1149846, 1138201, 1138202, 1138900, 1141143, and numerous others extending through expiration dates up to December 31, 2028. Approximately 934,577 bottles are subject to this recall.
Patients taking Corlanor should consult their healthcare provider or pharmacist immediately regarding their current supply. Do not discontinue use without medical guidance. Patients with questions may contact Amgen Inc. through official product recall channels.
The recalled product
- Product
- CORLANOR (IVABRADINE)
- Brand
- CORLANOR
- Manufacturer
- Amgen, Inc.
- Category
- Drug — Prescription Tablet
- Hazard
- foreign-substance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) Lot # 1138901
- Exp. Date 08/31/2026
- 1149846
- Exp. Date 04/30/2027 b) Lot #1138201
- 1138202
- 08/31/2026
- 1138900
- 1141143
- 1140280
- 1140281
- 1142063
- Exp. Date 10/31/2026
- 1142062
- 1142942
- 1142943
- Exp. Date 11/30/2026
- 1144081
- 1144104
- Exp. Date 12/31/2026
- 1146373
UPCs (2)
- 0355513800600
- 0355513810609
Distribution
Distributed nationwide across the United States.
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