The Recall Desk
Agency classClass IOur severity:SevereFDA (Food)·H-0284-2026·Announced 2025-12-17

Cinacalcet 60 mg tablets recalled over a nitrosamine impurity above limits

Cipla USA is recalling 15,744 bottles of Cinacalcet Hydrochloride Tablets, 60 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product tested positive Salmonella ."

Plain-English summary

Cinacalcet Hydrochloride Tablets, 60 mg, 30 tablets per bottle, manufactured for Cipla USA, Inc. of Warren, New Jersey, under NDC 69097-411-02, are being recalled.

The recall follows CGMP deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

The recall covers 15,744 bottles from lot 5PB0164, expiry 1/31/2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.

Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.

The recalled product

Product
Deep-brand PREMIUM Select Mixed Vegetables 4 way KEEP FROZEN a) Net Wt. 3.85 LB. (1.75 kg); b) Net Wt. 2 LB (907 g)
Manufacturer
CHETAK NEW YORK LLC
Category
Drug — Calcimimetic
Hazard
Affected units
3,509,532

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 (18)

  • Lots: a) 24354
  • 25001
  • 25032
  • 25035
  • 25068
  • 25099
  • 25100
  • 25122
  • 25133
  • 25160
  • 25195
  • b) 25001
  • 25020
  • 25044
  • 25072
  • 25080
  • 25167
  • 25198

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 52 recalled by CHETAK NEW YORK LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

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