Class IIOngoing

Lanthanum Carbonate chewable tablets recall

FDA recall D-0217-2026 · initiated Oct 24, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed stability specifications: Out of specification for hardness test

Details

Product: 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.
Recalling company: Cipla Limited
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Oct 24, 2025
FDA report date: Dec 17, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0217-2026 ↗

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