RecallRadar

FDA Drug recall D-0217-2026

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc…

On 2025-12-17 the FDA classified a Class II recall of Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc… by Cipla Usa, citing failed stability specifications: Out of specification for hardness test.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0217-2026
ClassificationClass II
Statusongoing
Initiated2025-10-24
Published2025-12-17
Last updated2026-09-13 11:52 UTC
CompanyCipla Usa
DistributionUS

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

Failed stability specifications: Out of specification for hardness test

Identifiers

ndc69097-934-57
ndc69097-934-98
ndc69097-935-89
ndc69097-935-98
ndc69097-936-65
ndc69097-936-98
code_infolot# NB240315, exp 12/31/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0217-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.