United StatesLanthanum carbonate chewable tablets, 1000 mg, in 10x9 bottles per patient pack cartons (NDC 69097-936-98 and Carton NDC 76282-478-90 / Bottle NDC 76282-478-13) manufactured for Cipla USA/Exelan are recalled; affected lot numbers NB240315 and NB240314, expiring 12/31/2025, were sold nationwide in the United States. The recall was initiated because the tablets failed stability specifications and were out of specification for the hardness test.
What's being recalled
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.
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.
Recalling firm: Cipla USA, Inc., Warren, NJ, United States.
How to identify it
lot# NB240315, exp 12/31/2025 Lot# NB240314, exp 12/31/2025
The hazard
Failed stability specifications: Out of specification for hardness test
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)