More than 900,000 bottles of prescription heart and kidney medications have been recalled across the United States after regulators identified potential contamination risks and manufacturing deviations, according to the U.S. Food and Drug Administration (FDA), raising concerns for patients treated for chronic cardiovascular and kidney-related conditions.
Nationwide Recall Affects Multiple Prescription Drugs
The recall involves at least 944,142 bottles of medications distributed by Amgen, Inc., used in the treatment of conditions such as chronic heart failure, chronic kidney disease and hyperparathyroidism.
The FDA stated that the action was taken due to the “presence of foreign substance” identified in some products, alongside reported deviations from Current Good Manufacturing Practice (CGMP) standards.
These manufacturing standards are designed to ensure pharmaceutical products meet required safety, quality and consistency levels before reaching patients.
Medications Included In The Recall
The recall covers multiple formulations and dosage strengths of Corlanor (ivabradine) and Sensipar (cinacalcet), both widely prescribed medications used in long-term treatment plans.
Corlanor is commonly used to treat certain types of heart failure, while Sensipar is prescribed for patients with parathyroid disorders, often linked to chronic kidney disease. The affected products include 5 mg and 7.5 mg Corlanor tablets in various bottle sizes, as well as 30 mg, 60 mg and 90 mg Sensipar tablets.
Multiple lot codes and expiration dates have been listed in the recall notice, covering products distributed over a wide timeframe extending into 2028.
| Medication | NDC | Lot Codes | Expiration Dates |
|---|---|---|---|
| Corlanor (ivabradine) 5-milligram tablets, 14-count | 55513-800-99 | 1138901; 1149846 | 08/31/2026; 04/30/2027 |
| Corlanor (ivabradine) 5-milligram tablets, 60-count | 55513-800-60 | 1138201; 1138202; 1138900; 1141143; 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; 1164099; 1165078; 1165079; 1165080; 1168005; 1168006; 1168007; 1169288; 1169289; 1172885 | 08/31/2026; 10/31/2026; 11/30/2026; 12/31/2026; 01/31/2027; 03/31/2027; 07/31/2027; 09/30/2027; 06/30/2027; 04/30/2027; 10/31/2027; 03/31/2028; 04/30/2028; 06/30/2028; 07/31/2028; 02/29/2028; 09/30/2028; 10/31/2028; 12/31/2028 |
| Sensipar (cinacalcet) 30-milligram tablets, 30-count | 55513-073-30 | 1156858 | 12/31/2027 |
| Sensipar (cinacalcet) 60-milligram tablets, 30-count | 55513-074-30 | 1157055 | 1/31/2028 |
| Corlanor (ivabradine) 7.5-milligram tablets, 60-count | 55513-810-60 | 1138203; 1142065; 1145151; 1145152; 1145153; 1148908; 1148909; 1162845; 1162846; 1166471; 1166472; 1166473; 1170615 | 07/31/2026; 02/28/2027; 05/31/2027; 11/30/2027; 05/31/2028; 08/31/2028 |
| Sensipar (cinacalcet) 90-milligram tablets, 30-count | 55513-075-30 | 1157056 | 02/29/2028 |
Regulatory Concerns Over Manufacturing Standards
The FDA’s classification of CGMP deviations indicates that manufacturing processes may not have fully met federally required production standards. These standards cover a wide range of controls, including ingredient quality, contamination prevention, production consistency and packaging integrity.
The presence of foreign substances in pharmaceutical products can trigger recalls even when the level of contamination risk is not immediately quantified, as regulators prioritise preventive action to protect patients.
Potential Impact On Patients
The recalled medications are commonly prescribed for long-term conditions, meaning many patients may already be in ongoing treatment programmes that rely on consistent daily dosing.
Patients using affected prescriptions are typically advised to continue treatment unless otherwise instructed by their healthcare provider, while pharmacies and distributors work to remove impacted batches from circulation.
Healthcare providers are expected to review patient prescriptions and supply alternative batches where necessary.
Distribution And Supply Chain Response
Amgen, Inc. is working with regulators and distributors to identify and isolate affected products across the supply chain. Pharmacies and healthcare facilities are being notified to check inventory against the listed lot numbers and expiration dates.
The recall spans multiple distribution channels nationwide, reflecting the scale of prescription medication supply chains in the U.S. healthcare system.
Ongoing Monitoring And Regulatory Action
The FDA continues to monitor the situation as investigations into the source of the manufacturing issues progress. Further updates may be issued if additional products are identified as part of the recall or if expanded safety concerns emerge.
Regulators have emphasised that pharmaceutical recalls are precautionary measures intended to reduce patient risk and maintain confidence in medication safety standards across the healthcare system.
