Lower risk Drug recall · FDA · Published June 29, 2026

Cipla Cinacalcet Tablets Recall: N-nitroso-cinacalcet Over Daily Intake Limit

Cipla USA recalls 30mg Cinacalcet tablets with N-nitroso-cinacalcet above safe daily intake levels. Consumers should contact Cipla for details on affected lots and return instructions.

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

🇺🇸 FDA recall #D-0661-2026Drug Cipla ›

Lower-risk recall

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Cipla USA is recalling 30mg Cinacalcet hydrochloride tablets that contain N-nitroso-cinacalcet above the acceptable daily intake level. This could pose a health risk with long-term use, though the recall does not specify immediate harm. Read more at govinfonow.com/recall/31172-cipla-cinacalcet-tablets-recall-n-nitroso-cinacalcet-over-daily-intake.

Source Summary by GovInfoNow · govinfonow.com/recall/31172-cipla-cinacalcet-tablets-recall-n-nitroso-cinacalcet-over-daily-intake · Updated August 7, 2026 · FDA enforcement record: FDA #D-0661-2026

Cite this page

“Cipla Cinacalcet Tablets Recall: N-nitroso-cinacalcet Over Daily Intake Limit.” GovInfoNow, updated August 7, 2026. https://govinfonow.com/recall/31172-cipla-cinacalcet-tablets-recall-n-nitroso-cinacalcet-over-daily-intake. Based on FDA recall #D-0661-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0661-2026%22&limit=1).

The FDA announced on June 29, 2026, that Cipla USA, Inc. is voluntarily recalling Cinacalcet Hydrochloride Tablets due to cGMP deviations involving N-nitroso-cinacalcet above the acceptable daily intake. The recall affects 31,824 bottles distributed nationwide.

How to tell if you have it

Cipla
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle
NDC 69097-410-02
Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027

The hazard

The recall is due to cGMP deviations resulting in the presence of N-nitroso-cinacalcet above the acceptable daily intake (ADI). The FDA has not reported specific incidents or injuries linked to this particular recall in the provided record.

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 (March 16, 2026), Cipla Lanreotide Injection Recall (March 13, 2026), and Cipla Nilotinib 200mg Capsules Recall (February 18, 2026). Other recent recalls of similar products include Cipla Phytonadione Injectable Emulsion Recall (October 31, 2025), Zydus Erythromycin Tablets Recall (April 29, 2026), and Zydus Clomipramine Capsules Recall (October 22, 2025).

How to tell if you have this one

Check for the product name 'Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle' with NDC 69097-410-02. Affected lots include 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027 and others listed in the recall.

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
USA Nationwide
NDC
69097-410-02, 69097-411-02, 69097-412-02

Recall number	Product, codes & lots	Quantity
D-0661-2026	Cinacalcet Hydrochloride Tablets, 30 mg, 30-count 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 #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027	31,824 bottles
D-0675-2026	Cinacalcet Hydrochloride Tablets, 60 mg, 30-count 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 #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027	N/A
D-0676-2026	Cinacalcet Hydrochloride Tablets, 90 mg, 30-count 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 #: 5PB0563, Exp 4/30/2027	N/A

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot numbers and expiration dates from the recall notice to determine if your tablets are affected.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 9 days after the firm started it.

Jun 29, 2026Firm started the recall
Jul 8, 2026Published in FDA’s Enforcement Report
Jul 9, 2026FDA classified it Class II

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

Similar recalls

Other Cipla recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31172-cipla-cinacalcet-tablets-recall-n-nitroso-cinacalcet-over-daily-intake">Cipla Cinacalcet Tablets Recall: N-nitroso-cinacalcet Over Daily Intake Limit (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-0661-2026 (June 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0661-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 7, 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.