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.
Reported: December 17, 2025 Initiated: October 24, 2025 #D-0218-2026
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
Details
- Recalling Firm
- Cipla USA, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide in the USA
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cipla USA, Inc.. Units affected: N/A.
Why was this product recalled? ▼
Failed stability specifications: Out of specification for hardness test
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 17, 2025. Severity: Moderate. Recall number: D-0218-2026.
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