Class II
Ongoing
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.
This recall is currently active, issued December 17, 2025. It was issued by Cipla Usa, Inc..
- Company
- Cipla Usa, Inc.
- Recall Initiated
- October 24, 2025
- Posted
- December 17, 2025
- Recall Number
- D-0218-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Warren, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed stability specifications: Out of specification for hardness test
Distribution
Nationwide in the USA
Lot / Code Info
Lot# NB240314, exp 12/31/2025
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