FDA recall, , Moderate risk
Amgen Corlanor and Sensipar Tablets
Corlanor (ivabradine) tablets contain a foreign substance, and Sensipar (cinacalcet) Tablets have CGMP deviations.
Summary by Recall Canary from the FDA notice
What happened
Amgen, Inc. of Thousand Oaks, California began a recall on June 4, 2026, for Corlanor (ivabradine) tablets due to the presence of a foreign substance, and for Sensipar (cinacalcet) Tablets due to CGMP deviations. The recall was added to the FDA's Enforcement Report and classified on June 23, 2026, with distribution nationwide within the United States. The affected products include Corlanor tablets in 7.5mg and 5mg strengths, and Sensipar tablets in 30mg, 60mg, and 90mg strengths.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
Incomplete list: 56 of 66 lot codes shown.
An NDC (National Drug Code) is usually printed on the drug's label.
Corlanor (ivabradine) tablets
Reason: Presence of Foreign Substance.
- Strength
- 7.5 mg
- NDC
- 55513-810-60
- Lot code
- 1138203
- 1142065
- 1145151
- 1145152
- 1145153
- 1148908
- 1148909
- 1162845
- 1162846
- 1166471
- 1166472
- 1166473
- 1170615
- Strength
- 5 mg
- NDC
- 55513-800-99
- 55513-800-60
- Lot code
- 1138901
- 1138201
- 1138202
- 1138900
- 1141143
- 1149846
- 1140280
- 1140281
- 1142063
- 1142062
- 1142942
- 1142943
- 1144081
- 1144104
- 1146373
- 1146374
- 1147491
- 1147492
- 1149843
- 1151113
- 1151890
- 1153401
- 1151114
- 1151115
- 1152412
- 1153399
- 1153400
- 1155834
- 1155835
- 1155836
- 1158480
- 1158481
- 1158482
- 1160354
- 1160355
- 1161593
- 1161594
- 1161595
- 1164097
- 1164098
Sensipar (cinacalcet) Tablets
Reason: CGMP Deviations
- Strength
- 60 mg
- NDC
- 55513-074-30
- Lot code
- 1157055
- Strength
- 30 mg
- NDC
- 55513-073-30
- Lot code
- 1156858
- Strength
- 90 mg
- NDC
- 55513-075-30
- Lot code
- 1157056
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Amgen, Inc.Thousand Oaks, California
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99077
- Recall numbers
- D-0612-2026 to D-0616-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
