The Recall Desk
ModerateFDA (Drugs)·D-0614-2026·Announced 2026-07-01

Sensipar Cinacalcet Tablets Recalled Due to CGMP Deviations

Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.

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 FDA classified this as Class II. The source does not report any hospitalization, deaths, serious injuries, or confirmed adverse health consequences. CGMP deviations represent a potential manufacturing control issue without demonstrated patient harm, placing this within the Moderate category.

Plain-English summary

Amgen, Inc. is recalling Sensipar (cinacalcet hydrochloride) 60 mg tablets distributed nationwide in the United States. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The affected product is distributed in 30-count bottles, NDC 55513-074-30, with Lot #1157055 and expiration date 1/31/2028.

This is a Class II recall initiated voluntarily by the firm. Patients taking this medication should not stop taking their prescription without consulting their healthcare provider. Patients who have this lot should contact their pharmacy or healthcare provider for guidance on obtaining an unaffected supply or alternative treatment.

The recalled product

Product
SENSIPAR (CINACALCET HYDROCHLORIDE)
Brand
SENSIPAR
Manufacturer
Amgen, Inc.
Category
Drug — Prescription Tablet
Hazard

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 #: 1157055
  • Exp. Date 1/31/2028

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

Same manufacturer · Amgen, Inc.

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Same hazard · cgmp deviation

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