The Recall Desk
HighFDA (Drugs)·D-0028-2025·Announced 2024-11-06

Prescription Drug Recall: Cinacalcet Tablets for N-nitroso Impurity

Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.

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 for manufacturing impurity (N-nitroso Cinacalcet) exceeding regulatory limits. While no illnesses have been reported, N-nitroso compounds are regulatory concerns; the Class II designation reflects FDA's determination of potential health risk from the manufacturing defect.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Cinacalcet 90 mg tablets in 30-count bottles due to a manufacturing issue identified during quality control.

The recall was triggered because certain lots contain N-nitroso Cinacalcet impurity at levels above the FDA's recommended interim limit. The impurity resulted from a Current Good Manufacturing Practice (CGMP) deviation during production.

The recall affects 10,584 bottles distributed nationwide. The affected lots are T2201443 (expiration March 2025) and T2300664 (expiration December 2025), identified by NDC 43598-369-30.

Patients currently taking Cinacalcet from these lots should contact their healthcare provider to discuss their medication. Healthcare providers should check inventory against the lot numbers and remove affected units from distribution. The FDA classified this as a Class II recall.

The recalled product

Product
CINACALCET (CINACALCET)
Brand
CINACALCET
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug
Hazard
Affected units
10,584

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 (4)

  • Lot# T2201443
  • Exp 03/2025
  • T2300664
  • Exp 12/2025.

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 →

Related recalls

Same brand · CINACALCET

Same manufacturer · Dr. Reddy's Laboratories, Inc.

See all →

Same hazard · n nitroso impurity

See all →