Lower risk Drug recall · FDA · Published October 24, 2025

Cipla Lanthanum Carbonate Tablets Recall: Hardness Test Failure

Cipla USA recalls 1000mg Lanthanum Carbonate chewable tablets due to hardness test failure. This may affect tablet integrity and safety. Check your Rx-only medication packaging for the recall.

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

🇺🇸 FDA recall #D-0217-2026Drug Cipla ›

Lower-risk recall

Failed stability specifications: Out of specification for hardness test

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Cipla USA is recalling Lanthanum Carbonate chewable tablets (1000mg) that failed stability testing for hardness. This could mean the tablets might break or crumble, potentially causing injury if taken. Read more at govinfonow.com/recall/31678-cipla-lanthanum-carbonate-tablets-recall-hardness-test-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/31678-cipla-lanthanum-carbonate-tablets-recall-hardness-test-failure · Updated August 17, 2026 · FDA enforcement record: FDA #D-0217-2026

Cite this page

“Cipla Lanthanum Carbonate Tablets Recall: Hardness Test Failure.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31678-cipla-lanthanum-carbonate-tablets-recall-hardness-test-failure. Based on FDA recall #D-0217-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0217-2026%22&limit=1).

Cipla USA, Inc. recalled Lanthanum Carbonate chewable tablets due to failed stability specifications, the FDA said on Oct. 24, 2025. The voluntary Class II recall affects 1,180 boxes distributed nationwide.

How to tell if you have it

Brand: Cipla
Product: Lanthanum Carbonate chewable tablets, 1000mg*
NDC: 69097-936-98
Lot code: NB240315
Expiration date: 12/31/2025
Quantity: 1,180 boxes

The hazard

The tablets failed stability specifications because they were out of specification for the hardness test. The FDA classified this as a Class II recall.

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), Cipla Lanreotide Injection Recall (March 13, 2026), and Cipla Phytonadione Injectable Emulsion Recall (Oct. 31, 2025). Additional recent recalls include Lannett Niacin Extended-release Tablets Recall (May 27, 2026) and H.E.B Extra Strength Calcium Antacid Tablets Recall (May 28, 2026).

How to tell if you have this one

Check for the product name 'Lanthanum Carbonate chewable tablets, 1000mg', 10x9 bottles per patient pack carton, and Rx-only labeling. The lot number NB240315 was manufactured until December 31, 2025.

Brand
Cipla
Category
Drug

FDA recall event · 2 products

All 2 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

Recall number	Product, codes & lots	Quantity	NDC
D-0217-2026	Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.; lot# NB240315, exp 12/31/2025	1180 boxes	69097-934-57, 69097-934-98, 69097-935-89, 69097-935-98, 69097-936-65, 69097-936-98
D-0218-2026	Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.; Lot# NB240314, exp 12/31/2025	N/A	76282-476-45, 76282-476-90, 76282-477-15, 76282-477-90, 76282-478-13, 76282-478-90

Based on the official FDA remedy

What to do — step by step

Check Product Packaging
Look for the product name, dosage, and packaging details as listed in the recall notice.

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 54 days after the firm started it.

Oct 24, 2025Firm started the recall
Dec 5, 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.

✎ GovInfoNow

Questions people ask

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

Is this product safe to take?

The recall indicates the tablets failed hardness testing, but the product is still safe to take if used as directed. However, the manufacturer recommends checking for the recall.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31678-cipla-lanthanum-carbonate-tablets-recall-hardness-test-failure">Cipla Lanthanum Carbonate Tablets Recall: Hardness Test Failure (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-0217-2026 (October 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0217-2026 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.