D-0587-2026 Class II Ongoing
FDA drug recall D-0587-2026 was initiated by Golden State Medical Supply Inc. on May 29, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. The recall status is ongoing. Affected quantity: 2,961 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 17, 2026
- Initiation Date
- May 29, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,961 bottles
Product description
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.
Reason for recall
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Distribution pattern
Within the U.S Market.
Code information
Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0587-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026