HIGH

Invagen Pharmaceuticals Recalls Lanthanum Carbonate Tablets for Safety Risk

Invagen Pharmaceuticals recalled Lanthanum Carbonate chewable tablets on October 24, 2025, due to stability issues. The tablets failed hardness specifications, posing a high hazard level. Healthcare providers and consumers should stop using the product immediately.

Quick Facts at a Glance

Recall Date
October 24, 2025
Hazard Level
HIGH
Brands
LANTHANUM CARBONATE, Exelan Pharmaceuticals, Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed stability specifications: Out of specification for hardness test

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: N/A

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About This Product

Lanthanum Carbonate chewable tablets are used to manage phosphate levels in patients with chronic kidney disease. Consumers typically purchase this medication as part of a treatment regimen for managing their condition.

Why This Is Dangerous

The product's failure in hardness testing means that the tablets may not dissolve properly in the body. This could lead to inadequate treatment for patients requiring phosphate control.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks if they continue using the affected product. Immediate cessation is necessary to avoid potential complications.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the product packaging.
  2. Verify the expiration date as 12/31/2025.
  3. Compare with Lot# NB240314 to determine if affected.

Where to find product info

Lot numbers and expiration dates are typically found on the bottom of the bottle or carton.

What timeline to expect

Allow 4-6 weeks for processing of refunds or replacements.

If the manufacturer is unresponsive

  • Follow up with the manufacturer via phone or email.
  • Document all correspondence for your records.
  • Consider filing a complaint with the FDA if issues persist.

How to prevent similar issues

  • Look for FDA approval when purchasing medications.
  • Check for stability testing results where available.
  • Consult with healthcare providers before switching medications.

Documentation advice

Maintain records of your purchase, including receipts and any communication with the manufacturer.

Product Details

The recall affects Lanthanum Carbonate chewable tablets, 1000mg per tablet. The product is sold in patient pack cartons containing ten 9-bottle units. The NDC codes are 76282-478-90 for the carton and 76282-478-13 for the bottle.

Key Facts

  • Recall initiated on October 24, 2025
  • Product failed hardness specifications
  • National distribution in the USA
  • Contact healthcare provider for guidance

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLanthanum Carbonate Chewable Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot# NB240314
exp 12/31/2025
UPC Codes
76282-476
76282-477
76282-478
+6 more
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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