FDA Recall D-0158-2026

Golden State Medical Supply Inc. · Camarillo, CA

Class II Ongoing 206 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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

Quantity: 24,869 bottles

Reason for recall

Failed Dissolution Specifications

Recall record

Recall number: D-0158-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-10-20
Classified by FDA Center: 2025-11-19
FDA published: 2025-11-26
Recalling firm: Golden State Medical Supply Inc.
Firm location: Camarillo, CA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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