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 Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighCinacalcet tablets recalled for nitroso impurity above FDA limits
FDA (Drugs) · 2024-11-06
- HighCinacalcet tablets recalled for manufacturing impurity exceeding FDA limits
FDA (Drugs) · 2024-11-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27