Recall archive / FDA drug enforcement
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharma... — FDA record D-0158-2026
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 Oct 20, 2025. 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
- NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90
- Reason
- Failed Dissolution Specifications
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 24,869 bottles
- Agency-reported status
- Ongoing
- Source record identifier
- D-0158-2026
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 | Lot, expiry: GS044385, exp 10/2025 ; GS044979, exp 10/2025 ; GS045797, exp 12/2025 ; GS046415, exp 12/2025 ; GS047197, exp 02/2026 ; GS047786, exp 02/2026 ; GS048477, exp 02/2026 ; GS049480, exp 03/2026 ; GS048873, exp 03/2026 ; GS049733, exp 03/2026 ; GS050224, exp 03/2026 ; GS050721, exp 03/2026 ; GS050722, exp 03/2026 ; GS051145, exp 03/2026 ; GS051726, exp 03/2026 ; GS052484, exp 03/2026 ; GS053612, exp 04/2026 ; GS054987, exp 05/2026 ; GS054409, exp 05/2026 ; GS055697, exp 05/2026 ; GS056192, exp 05/2026 ; GS056886, exp 05/2026 ; GS058077, exp 05/2026 ; GS057330, exp 05/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 26, 2025
- Recall initiation date
- Oct 20, 2025
- Center classification date
- Nov 19, 2025
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.