D-0218-2026 Class II Ongoing
FDA drug recall D-0218-2026 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.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 17, 2025
- Initiation Date
- Oct 24, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot# NB240314, 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-0218-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026