The Recall Desk
HighFDA (Drugs)·D-0110-2025·Announced 2024-12-11

Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits

AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.

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 illnesses or injuries. The hazard—a nitrosamine impurity above acceptable limits—represents a risk-of-harm product where contamination has been identified but no adverse health effects have been reported. Per the rubric, this scenario scores as High (3).

Plain-English summary

AvKARE is recalling 2,796 bottles of Cinacalcet Tablets, 90 mg, 30-count bottles (Lot #44405, Exp 12/31/2024, NDC 42291-461-30) distributed nationwide due to manufacturing deviations.

Testing identified the presence of N-Nitroso-Cinacalcet, a nitrosamine drug substance-related impurity, at levels exceeding the acceptable daily intake limit for this substance. This was discovered during current good manufacturing practice (CGMP) quality control.

Patients currently taking affected medication should consult their healthcare provider or pharmacist. Do not stop taking the medication without medical guidance. Return affected bottles to a pharmacy for proper disposal.

The recalled product

Product
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Manufacturer
AvKARE
Category
Drug — Prescription Medication
Hazard
  • nitrosamine-impurity
  • manufacturing-deviation

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 (2)

  • Lot #: 44405
  • Exp 12/31/2024

Distribution

Distributed nationwide across the United States.

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