The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0661-2026·Announced 2026-07-08

Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits

Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 30 mg tablets due to the presence of N-nitroso-cinacalcet above the acceptable daily intake. The affected product was distributed nationwide.

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 FDA classified this as a Class II recall. The hazard involves an N-nitroso impurity above acceptable levels, which is a potential carcinogenic risk. Although no reported illnesses are stated in the source, this represents a risk-of-harm product with a known chemical contamination exceeding safety thresholds, warranting a High severity classification.

Plain-English summary

Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottles (NDC 69097-410-02), manufactured by Cipla Ltd. in India. A total of 31,824 bottles have been recalled. The recall was initiated because of the presence of N-nitroso-cinacalcet above the acceptable daily intake, a deviation from current good manufacturing practice (cGMP) standards.

The affected product was distributed nationwide. Affected lot numbers include 5PB0465, 5PB0466, and 5PB0557 (expiring 4/30/2027), as well as 5PB0629, 5PB0630, 5PB0633, 5PB0637, and 5PB0638 (expiring 6/30/2027).

Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance on their treatment. Healthcare providers and pharmacists should stop dispensing product from the affected lots and quarantine remaining inventory.

The recalled product

Product
CINACALCET (CINACALCET)
Brand
CINACALCET
Manufacturer
Cipla USA, Inc.
Category
Drug — Prescription Tablet
Hazard
Affected units
31,824

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 (10)

  • Lot #: 5PB0465
  • 5PB0466
  • 5PB0557
  • Exp 4/30/2027
  • 5PB0629
  • 5PB0630
  • 5PB0633
  • 5PB0637
  • 5PB0638
  • Exp 6/30/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cipla USA, 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.

See all 3 products in this recall →

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