The Recall Desk
HighFDA (Drugs)·D-0026-2025·Announced 2024-11-06

Cinacalcet tablets recalled for manufacturing impurity exceeding FDA limits

Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a theoretical hazard (manufacturing defect producing impurity above safety limits) and no reported adverse events justifies High severity per the rubric's criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Cinacalcet 30 mg tablets distributed nationwide. The recall involves 285,126 bottles across multiple lot numbers with expiration dates ranging from November 2024 through August 2026.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations that resulted in N-nitroso Cinacalcet impurity above the FDA's recommended interim limit.

Patients taking Cinacalcet from affected lots should contact their healthcare provider to determine if they have been impacted and to discuss next steps. Patients should not discontinue their medication without consulting their healthcare provider, as abrupt discontinuation could affect their medical condition.

The recalled product

Product
CINACALCET (CINACALCET)
Brand
CINACALCET
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug
Hazard
Affected units
285,126

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 (20)

  • Lot# T2200120
  • T2200121
  • T2200119
  • T2200116
  • T2200118
  • T2200117
  • Exp 11/2024
  • T2200695
  • T2200694
  • T2200696
  • T2200697
  • Exp 01/2025
  • T2201426
  • T2201428
  • T2201432
  • T2201427
  • T2201430
  • T2201429
  • T2201431
  • Exp 03/2025

UPCs (1)

  • 0343598369303

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Dr. Reddy's Laboratories, 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 3 products in this recall →

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