D-0218-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 17, 2025
- Initiation Date
- October 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Reason for Recall
Failed stability specifications: Out of specification for hardness test
Distribution Pattern
Nationwide in the USA
Code Information
Lot# NB240314, exp 12/31/2025