PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: December 17, 2025 Initiated: October 24, 2025 #D-0217-2026

Product Description

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.

Reason for Recall

Failed stability specifications: Out of specification for hardness test

Details

Recalling Firm
Cipla USA, Inc.
Units Affected
1180 boxes
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., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.. Recalled by Cipla USA, Inc.. Units affected: 1180 boxes.
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-0217-2026.