Niacin extended release tablets recalled after failing dissolution specifications
Golden State Medical Supply is recalling 24,869 bottles of Niacin Extended-Release Tablets USP 1,000 mg for failed dissolution specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a specification failure: the record states only that dissolution specifications were not met, without describing a health consequence or reporting injury.
Plain-English summary
Niacin Extended-Release Tablets, USP, 1,000 mg, in 90-tablet bottles, manufactured by Kremers Urban Pharmaceuticals of Seymour, Indiana and packaged by GSMS of Camarillo, California, are being recalled for failed dissolution specifications.
The recall covers 24,869 bottles across lots including GS044385 and GS044979 (which expired October 2025) and GS045797 and GS046415 (which expired December 2025). The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the dissolution failure without describing a health consequence, and reports no injuries. This is a prescription product, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Lipid-lowering agent
- Affected units
- 24,869
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot
- expiry: GS044385
- exp 10/2025
- GS044979
- GS045797
- exp 12/2025
- GS046415
- GS047197
- exp 02/2026
- GS047786
- GS048477
- GS049480
- exp 03/2026
- GS048873
- GS049733
- GS050224
- GS050721
- GS050722
- GS051145
- GS051726
Distribution
Distributed nationwide across the United States.
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