The Recall Desk
SevereFDA (Drugs)·D-0676-2026·Announced 2026-07-08

Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels

Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a prescription drug with an impurity (N-nitroso compound) above acceptable intake thresholds. Per the rubric, FDA Class II with manufacturing deviations that pose potential health risk meets the Severe criterion, even though no illnesses have been reported.

Plain-English summary

Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottles (NDC 69097-412-02) due to current Good Manufacturing Practice (cGMP) deviations. The recalled lot (Lot #5PB0563, expiration date 4/30/2027) contains N-nitroso-cinacalcet at levels above the acceptable daily intake.

Cinacalcet is a prescription medication used to treat certain conditions related to calcium and parathyroid hormone levels. Patients currently taking this product should not stop taking their medication without consulting their healthcare provider. Consumers with questions or who have experienced any adverse effects should contact their healthcare provider or pharmacist.

The product was distributed nationwide. Cipla USA, Inc., located at 10 Independence Boulevard, Suite 300, Warren, NJ 07059, is conducting this recall. The FDA has classified this as a Class II recall.

The recalled product

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

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 #: 5PB0563
  • Exp 4/30/2027

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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