The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0675-2026·Announced 2026-07-08

Cinacalcet Tablets Recalled for cGMP Deviations

Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 60 mg due to cGMP deviations involving the presence of N-nitroso-cinacalcet above acceptable daily intake levels.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 a potential safety concern (N-nitroso impurity above acceptable intake levels). Class II recalls with pharmaceutical safety hazards warrant a Severe classification per the rubric.

Plain-English summary

Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 60 mg (30-count bottles, NDC 69097-411-02) distributed nationwide. The recall is due to cGMP deviations: the presence of N-nitroso-cinacalcet in the product at levels above the acceptable daily intake (ADI).

The affected lots are 5PB0165 and 5PB0166 (expiration 1/31/2027); 5PB0552 (expiration 4/30/2027); and 5PB0642, 5PB0643, and 5PB0644 (expiration 6/30/2027). Cinacalcet is a prescription medication used to treat hyperparathyroidism.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Do not discontinue use of the medication without consulting a healthcare professional.

The recalled product

Product
CINACALCET (CINACALCET)
Brand
CINACALCET
Manufacturer
Cipla USA, Inc.
Category
Drug — Prescription Pharmaceutical
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 (9)

  • Lot #: 5PB0165
  • 5PB0166
  • Exp 1/31/2027
  • 5PB0552
  • Exp 4/30/2027
  • 5PB0642
  • 5PB0643
  • 5PB0644
  • 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 →

Related recalls

Same brand · CINACALCET

Same manufacturer · Cipla USA, Inc.

See all →

Same hazard · n nitroso impurity

See all →

Similar recalls