Unrated Drug recall · FDA · Published November 14, 2025

Cipla Cinacalcet Tablets Recall: Nitrosamine Impurity Risk

Cipla USA recalls 90mg Cinacalcet tablets due to nitrosamine impurity exceeding safe limits. Patients should consult their doctor for alternatives.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0226-2026Drug Cipla ›

Recall notice

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

Take action

Contact the company

Recalling firmCipla USA, Inc.10 Independence Blvd · Warren, NJ 07059-2730

✎ GovInfoNow plain-language explainer

Cipla USA is recalling 90mg Cinacalcet hydrochloride tablets that contain a nitrosamine impurity above safe levels. This could pose health risks to patients using these prescription medications. Read more at govinfonow.com/recall/31636-cipla-cinacalcet-tablets-recall-nitrosamine-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31636-cipla-cinacalcet-tablets-recall-nitrosamine-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0226-2026

Cite this page

“Cipla Cinacalcet Tablets Recall: Nitrosamine Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31636-cipla-cinacalcet-tablets-recall-nitrosamine-impurity-risk. Based on FDA recall #D-0226-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0226-2026%22&limit=1).

The FDA announced on 2025-11-14 that Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets due to CGMP deviations involving a nitrosamine impurity above acceptable limits. The recall affects 12,576 bottles distributed nationwide.

How to tell if you have it

Brand: Cipla
Product: Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle
NDC: 69097-412-02
Lot: 5PB0183
Expiration date: 1/31/2027

The hazard

The recall is due to CGMP deviations resulting in the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. The record does not report specific incidents or injuries associated with this recall.

Context

GovInfoNow's records show Cipla USA, Inc. has 12 other recalls on record since 2023-06-27. Other recent recalls of similar products include Cipla Cinacalcet Tablets Recall: N-nitroso-cinacalcet Risk (2026-06-29) and Cipla Cinacalcet Tablets Recall: N-Nitroso Contamination Risk (2026-03-16). Other recent recalls of similar products include Asclemed Duloxetine Capsules Recall: Nitrosamine Impurity Risk (2026-05-14) and Zydus Clomipramine Capsules Recall: Nitrosamine Impurities Risk (2025-10-22).

How to tell if you have this one

Check for the product name 'Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle' with NDC 69097-412-02 and lot number 5PB0183, expiring 1/31/2027.

Brand
Cipla
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the US
NDC
69097-410-02, 69097-411-02, 69097-412-02

Recall number	Product, codes & lots	Quantity
D-0224-2026	Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02; Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027	63,504 bottles
D-0225-2026	Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02; Lot 5PB0164, exp 1/31/2027	15,744 bottles
D-0226-2026	Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02; Lot 5PB0183, exp 1/31/2027	12,576 bottles

Based on the official FDA remedy

What to do — step by step

Consult Your Doctor
Talk to your healthcare provider about alternative treatments for your kidney condition.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

Nov 14, 2025Firm started the recall
Dec 9, 2025FDA classified it Class II
Dec 17, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31636-cipla-cinacalcet-tablets-recall-nitrosamine-impurity-risk">Cipla Cinacalcet Tablets Recall: Nitrosamine Impurity Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0226-2026 (November 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0226-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.