Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits
Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a nitrosamine impurity exceeding the FDA's acceptable daily intake limit—a manufacturing quality issue with direct health risk implications. No illnesses or adverse events have been reported. This meets the High severity threshold as a risk-of-harm product without reported injury.
Plain-English summary
Accord Healthcare, Inc. is recalling Cinacalcet 90 mg tablets distributed nationwide in the United States and Puerto Rico. The recall affects two specific lots: Lot #M2303264 (expiration 01/2026) and Lot #M2306979 (expiration 04/2026). The tablets are manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified N-nitroso-cinacalcet, a nitrosamine impurity, present at levels above the FDA's acceptable daily intake (ADI) limit. Nitrosamine impurities in pharmaceutical products require strict manufacturing controls to ensure patient safety.
Patients currently taking Cinacalcet from affected lots should contact their pharmacy or healthcare provider to verify whether their medication is part of this recall. Patients should not discontinue use without consulting their healthcare provider, as abrupt discontinuation could affect their medical condition. Affected medication should be returned to the pharmacy where it was dispensed. No adverse health events associated with this impurity have been reported to date.
The recalled product
- Product
- CINACALCET (CINACALCET)
- Brand
- CINACALCET
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Category
- Drug — Prescription Medication
Distribution
Part of a larger recall action
This product is one of 3 recalled by ACCORD HEALTHCARE, 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.
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Similar recalls
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