FDA recall D-0217-2026

Cipla USA, Inc. · Class II · drug

Product

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

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-10-24
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0217-2026