Lower risk Drug recall · FDA · Published March 16, 2026

Cipla Cinacalcet Tablets Recall: N-Nitroso Contamination Risk

Cipla USA recalls 30mg Cinacalcet tablets due to N-Nitroso contamination exceeding safe limits. Affected lots manufactured in India for US distribution. Consumers should contact Cipla for details.

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

🇺🇸 FDA recall #D-0449-2026Drug Cipla ›

Lower-risk recall

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Cipl: USA recalls 30mg Cinacalcet tablets made by Cipla Ltd. in India for US distribution. The tablets contain N-Nitroso Cinacalcet above safe levels, which could pose health risks with long-term use. Read more at govinfonow.com/recall/31429-cipla-cinacalcet-tablets-recall-n-nitroso-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31429-cipla-cinacalcet-tablets-recall-n-nitroso-contamination-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0449-2026

Cite this page

“Cipla Cinacalcet Tablets Recall: N-Nitroso Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31429-cipla-cinacalcet-tablets-recall-n-nitroso-contamination-risk. Based on FDA recall #D-0449-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0449-2026%22&limit=1).

Cipla USA, Inc. recalled Cinacalcet Hydrochloride Tablets due to cGMP deviations and the presence of N-Nitroso Cinacalcet above acceptable limits, according to the FDA. The agency announced the Class II recall on March 16, 2026.

How to tell if you have it

Brand: Cipla
Product: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle
NDC: 69097-410-02
Lots: 4PB0526, 4PB0527, 4PB0528 (exp September-2026); 5PB0173 (exp January-2027)
Distribution: Nationwide in the USA

The hazard

The recall addresses cGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. The FDA's FAERS database contains 2,514 adverse-event reports naming this product, with 2,169 marked serious and 415 listing a death.

Context

GovInfoNow's records show Cipla USA, Inc. has 12 other recalls on record since June 27, 2023. Other recent recalls of similar products include Cipla Cinacalcet Tablets Recall (June 29, 2026) and Cipla Lanreotide Injection Recall (March 13, 2026). Additional recent recalls include Cipla Nilotinib 200mg Capsules Recall (Feb. 18, 2026), Cipla Phytonadione Injectable Emulsion Recall (Oct. 31, 2025), Zydus Mirabegron 25mg Tablets Recall (Aug. 5, 2026), and Zydus Erythromycin Tablets Recall (April 29, 2026).

How to tell if you have this one

Check for NDC code 69097-410-02 on the bottle. Affected lots include 4PB0526-4PB0528 (expiring September 2026) and 5PB0173 (expiring January 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 USA
NDC
69097-410-02, 69097-411-02, 69097-412-02

Recall number	Product, codes & lots	Quantity
D-0449-2026	Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02; Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027	113,336 bottles
D-0450-2026	Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02; Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027	96,096 bottles
D-0451-2026	Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02; Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027	63,192 bottles

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for NDC code 69097-410-02 on the bottle label.
Contact Cipla
Reach out to Cipla USA for specific instructions on handling affected lots.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 37 days after the firm started it.

Mar 16, 2026Firm started the recall
Apr 10, 2026FDA classified it Class II
Apr 22, 2026Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are these tablets safe to use?

The recall indicates N-Nitroso levels exceed safe limits, so they should not be used without consulting a healthcare provider.

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Link to this recall

<a href="https://govinfonow.com/recall/31429-cipla-cinacalcet-tablets-recall-n-nitroso-contamination-risk">Cipla Cinacalcet Tablets Recall: N-Nitroso Contamination 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-0449-2026 (March 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0449-2026 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.