FDA recall D-0218-2026

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., (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

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-0218-2026