Recall
FDAHealthOctober 24, 2025

Cipla USA, Inc. — 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

⚠️ Failed stability specifications: Out of specification for hardness test

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 24, 2025

Nationwide in the USA

What's affected?

Product
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.
UPC
0376282478135
Lot code
NB240314

Additional details

Lot# NB240314, exp 12/31/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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