Recall archive / FDA drug enforcement
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban... — FDA record D-0587-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 29, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 2,961 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0587-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Within the U.S Market.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 17, 2026
- Recall initiation date
- May 29, 2026
- Center classification date
- Jun 11, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.