Cinacalcet tablets recalled for nitroso impurity above FDA limits
Dr. Reddy's Laboratories is recalling Cinacalcet 60 mg tablets nationwide because testing detected N-nitroso impurity exceeding FDA interim limits. The recall affects 35,880 bottles.
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 no reported hospitalizations or injuries. N-nitroso impurity above FDA limits represents a risk-of-harm product without reported injury, consistent with severity score 3 per the rubric.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Cinacalcet 60 mg tablets, supplied in 30-count bottles. The affected product is distributed nationwide across the United States. The recall encompasses 35,880 bottles across seven lot numbers with various expiration dates ranging from January 2025 through August 2026.
The recall was initiated due to a current good manufacturing practice (CGMP) deviation identified during quality control testing. Testing detected the presence of N-nitroso Cinacalcet impurity at levels above the FDA's recommended interim limit.
Patients taking Cinacalcet from the affected lots should consult their healthcare provider or pharmacist before discontinuing the medication. Do not discard the medication without professional guidance, as abrupt discontinuation may affect your treatment. Healthcare providers should identify patients who may have received affected lots and contact them regarding alternative options.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- nitroso-impurity
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 (14)
- Lot# T2200698
- Exp 01/2025
- T2201444
- Exp 03/2025
- T2202827
- Exp 06/2025
- T2300531
- Exp 12/2025
- T2301696
- Exp 02/2026
- T2304726
- Exp 08/2026
- T2400480
- Exp 11/2026.
UPCs (1)
- 0343598369303
Distribution
Distributed nationwide across the United States.
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