Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Man...
FDA Recall #D-0217-2026 — Class II — October 24, 2025
Product Description
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.
Reason for Recall
Failed stability specifications: Out of specification for hardness test
Recalling Firm
Cipla USA, Inc. — Warren, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1180 boxes
Distribution
Nationwide in the USA
Code Information
lot# NB240315, exp 12/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated