Corlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets nationwide due to the presence of a foreign substance. Patients should consult their healthcare provider before stopping this medication.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a foreign substance of unspecified nature, and the source text contains no information about actual harm or risk category, placing it in the moderate range for a precautionary recall.
Plain-English summary
Amgen, Inc. is recalling multiple lots of Corlanor (ivabradine) 7.5mg tablets, a prescription heart medication used to reduce heart rate in heart failure patients. The recall is due to the presence of a foreign substance found in affected batches.
The recalled lots include: 1138203 and 1142065 (expiration 07/31/2026); 1145151, 1145152, and 1145153 (expiration 02/28/2027); 1148908 and 1148909 (expiration 05/31/2027); 1162845 and 1162846 (expiration 11/30/2027); 1166471, 1166472, and 1166473 (expiration 05/31/2028); and 1170615 (expiration 08/31/2028). The product is distributed nationwide in 60-count bottles (NDC 55513-810-60).
Patients currently taking Corlanor from the affected lots should not stop taking the medication without consulting their healthcare provider, as abrupt discontinuation could be harmful. Patients should contact their pharmacy or healthcare provider with questions about whether their medication is affected by this recall.
The recalled product
- Product
- CORLANOR (IVABRADINE)
- Brand
- CORLANOR
- Manufacturer
- Amgen, Inc.
- Hazard
- foreign-substance
- contamination
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 (19)
- 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
UPCs (2)
- 0355513800600
- 0355513810609
Distribution
Distributed nationwide across the United States.
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