FDA recall record

NIACIN GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets recall — FDA D-0587-2026

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the…

Class IIclassification
D-0587-2026official record ID
Jun 17, 2026report date

Recall record at a glance

Official recordD-0587-2026
CategoryDrug Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmGolden State Medical Supply Inc.
Report dateJun 17, 2026
Recall initiation dateMay 29, 2026
Quantity2,961 bottles
LocationCamarillo, CA, United States

Official 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.

Why the product was recalled

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 information

Within the U.S Market.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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