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.
- Brand
- LANTHANUM CARBONATE
- 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.
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