Sensipar (Cinacalcet Hydrochloride) Tablets Recalled for CGMP Deviations
Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 for CGMP deviations. The source text contains no reports of illness, injury, or hospitalization related to this manufacturing deviation, and the hazard is theoretical rather than confirmed.
Plain-English summary
Amgen, Inc. is voluntarily recalling Sensipar (cinacalcet hydrochloride) Tablets, 30mg, in 30-count bottles. The recall affects 9,565 bottles distributed nationwide within the United States. The specific affected lot is Lot #1156858 with an expiration date of 12/31/2027, NDC 55513-073-30.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Sensipar is a prescription medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease.
Patients currently taking Sensipar from the recalled lot should contact their healthcare provider or pharmacist immediately. Do not stop taking the medication without medical guidance, as discontinuation without professional advice may affect treatment. Healthcare providers and patients can contact Amgen, Inc. at One Amgen Center Drive, Thousand Oaks, California 91320-1799 for additional information about the recall.
The recalled product
- Product
- SENSIPAR (CINACALCET HYDROCHLORIDE)
- Brand
- SENSIPAR
- Manufacturer
- Amgen, Inc.
- Affected units
- 9,565
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 (2)
- Lot#: 1156858
- Exp. Date 12/31/2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Amgen, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same brand · SENSIPAR
- ModerateSensipar cinacalcet hydrochloride tablets recalled for CGMP deviations
FDA (Drugs) · 2026-07-01
- ModerateSensipar Cinacalcet Tablets Recalled Due to CGMP Deviations
FDA (Drugs) · 2026-07-01
Same manufacturer · Amgen, Inc.
See all →- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- HighInjectable Drug Recalled for Stability Issues at Expiration
FDA (Drugs) · 2025-03-26
- HighNeupogen Injectable Drug Recalled for Potential Stability Issues at Expiration
FDA (Drugs) · 2025-03-26
- HighMVASI Cancer Drug Recalled for Loose Container Crimp
FDA (Drugs) · 2022-05-18
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereCinacalcet Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-08
- HighCinacalcet 30 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- HighCinacalcet 90 mg tablets recalled over a nitrosamine impurity above limits
FDA (Drugs) · 2025-12-17
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- SevereCinacalcet 60 mg tablets recalled over a nitrosamine impurity above limits
FDA (Food) · 2025-12-17