The Recall Desk
HighFDA (Drugs)·D-0450-2026·Announced 2026-04-22

Cipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit

Cipla is recalling Cinacalcet Hydrochloride Tablets, 60 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 96,096 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, 60 mg, supplied in bottles of 30 tablets, NDC 69097-411-02. The product is manufactured by Cipla Ltd. in Patalganga, India. The action covers 96,096 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 include 4PB0215 and 4PB0216 (expiry March 2026), 4PB0515, 4PB0516 and 4PB0517 (expiry September 2026) and 5PB0167 (expiry January 2027), with the full list in the recall notice. 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
96,096

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
  • expiry: 4PB0215
  • 4PB0216
  • exp March-2026
  • 4PB0515
  • 4PB0516
  • exp September-2026
  • 4PB0517
  • 5PB0167
  • exp January-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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