The Recall Desk
HighFDA (Drugs)·D-0451-2026·Announced 2026-04-22

Cipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit

Cipla is recalling Cinacalcet Hydrochloride Tablets, 90 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 63,192 bottles are affected.

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 for an impurity above its acceptable daily intake limit, a product-quality failure creating risk of harm with no injuries reported.

Plain-English summary

Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 90 mg, supplied in bottles of 30 tablets, NDC 69097-412-02. The product is manufactured by Cipla Ltd. in Patalganga, India. The action covers 63,192 bottles.

The stated reasons are current good manufacturing practice deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. Nitrosamine impurities are controlled to defined intake limits because of their potential for long-term harm. The FDA classified the action as Class II.

Affected lots are 4PB0224 (expiry March 2026), 4PB0505, 4PB0506 and 4PB0507 (expiry September 2026) and 5PB0564 (expiry April 2027). Distribution was nationwide in the USA.

This is a prescription medicine. Patients should not stop taking a prescribed course without medical advice; anyone holding an affected lot should contact their pharmacy or prescriber about a replacement supply.

The recalled product

Product
CINACALCET (CINACALCET)
Brand
CINACALCET
Manufacturer
Cipla USA, Inc.
Category
Drug — Oral tablet
Hazard
Affected units
63,192

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
  • expiry: 4PB0224
  • exp March-2026
  • 4PB0505
  • 4PB0506
  • 4PB0507
  • exp September-2026
  • 5PB0564
  • exp April-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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Same hazard · nitrosamine impurity

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