FDA Drug recall D-0158-2026
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a sub…
- FDA Drug
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a sub… by Golden State Medical Supply, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0158-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-20 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Golden State Medical Supply |
| Distribution | US |
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
Identifiers
| ndc | 51407-267-90 |
|---|---|
| ndc | 51407-268-90 |
| code_info | Lot, expiry: GS044385, exp 10/2025 ; GS044979, exp 10/2025 ; GS045797, exp 12/2025 ; GS046415, exp 12/2025 ; GS0471…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Golden State Medical Supply
- Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30
FDA Drug · Class II · 2026-09-09 · Golden State Medical Supply - Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, M…
FDA Drug · Class II · 2026-08-26 · Golden State Medical Supply - GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc.,…
FDA Drug · Class II · 2026-06-17 · Golden State Medical Supply - Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo…
FDA Drug · Class III · 2026-05-27 · Golden State Medical Supply - Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camaril…
FDA Drug · Class III · 2026-05-27 · Golden State Medical Supply
All Golden State Medical Supply recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0158-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.