May 2026 FDA Recall Niacin by Golden State Medical Supply Inc.
D-0587-2026 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on May 29, 2026 for the product Niacin. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Within the U.S Market. and the recall is currently ongoing.

Recall Number: D-0587-2026

Reason for Recall
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.
Initiated
05-29-2026
Reported
06-17-2026
Quantity
2,961 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99127
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Within the U.S Market.
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.

Affected Packages Involved in this Recall

51407-267-90 Niacin
51407-268-90 Niacin