Lanthanum Carbonate Tablet, Chewable
FDA Recall NDC 69097-935
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lanthanum Carbonate (NDC 69097-935). A significant event, classified as Class II, was initiated on Oct 24, 2025 by Cipla Usa Inc.. The reported reason for this action was: "Failed stability specifications: Out of specification for hardness test"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed stability specifications: Out of specification for hardness test
Oct 24, 2025
Dec 17, 2025
1180 boxes
Recall Profile & Regulatory Data
Event ID
97855
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# NB240315, exp 12/31/2025
Affected Packages Involved in this Recall
69097-934-57Product
69097-934-98Product
69097-935-89Product
69097-935-98Product
69097-936-65Product
69097-936-98Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
