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
- n-nitroso-impurity
- manufacturing-defect
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.
Related recalls
Same brand · CINACALCET
- HighCinacalcet prescription drug recalled for nitrosamine impurity and manufacturing deviations
FDA (Drugs) · 2026-04-22
- HighFDA Recalls Cinacalcet Tablets for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-04-22
- HighCinacalcet tablets recalled due to N-nitroso impurity above acceptable limits
FDA (Drugs) · 2026-04-22
- HighDrug Recall: Cinacalcet tablets contain excess nitrosamine impurity
FDA (Drugs) · 2025-12-17
- HighCinacalcet tablets recalled for nitrosamine impurity above acceptable limits
FDA (Drugs) · 2025-12-17
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27