The Recall Desk
ModerateFDA (Drugs)·D-0616-2026·Announced 2026-07-01

Sensipar cinacalcet hydrochloride tablets recalled for CGMP deviations

Amgen, Inc. is recalling Sensipar (cinacalcet) 90mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed across the United States.

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, and the source text states the reason is CGMP deviations. The source does not report any illnesses, injuries, or hospitalizations. CGMP deviations without reported harm are typically Moderate severity unless other aggravating factors are present.

Plain-English summary

Amgen, Inc. is voluntarily recalling Sensipar (cinacalcet hydrochloride) 90mg tablets, 30-count bottles, nationwide in the United States. The recall was initiated on June 4, 2026, and classified as Class II by the FDA on June 23, 2026. The affected product is NDC 55513-075-30, Lot #1157056, with an expiration date of February 29, 2028.

The recall is due to 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 this medication should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should check their inventory for the affected lot number and quarantine the product. Customers with questions may contact the FDA's Emergency Operations Center.

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 #: 1157056
  • Exp. Date 02/29/2028

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.

See all →

Same hazard · cgmp deviation

See all →