D-0217-2026 Class II Ongoing
FDA drug recall D-0217-2026 was initiated by Cipla USA, Inc. on Oct 24, 2025 and is designated Class II. Reason for recall: Failed stability specifications: Out of specification for hardness test The recall status is ongoing. Affected quantity: 1180 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2025
- Initiation Date
- Oct 24, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1180 boxes
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
Distribution Pattern
Nationwide in the USA
Code Information
lot# NB240315, exp 12/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0217-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026