FDA Recall D-0096-2026

Lannett Company Inc. · Seymour, IN

Class II Ongoing 216 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, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46

Lot / code: Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026

Quantity: 46,848 90-count bottles

Reason for recall

Failed Dissolution Specifications

Recall record

Recall number: D-0096-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-10-10
Classified by FDA Center: 2025-10-22
FDA published: 2025-10-29
Recalling firm: Lannett Company Inc.
Firm location: Seymour, IN

Drug identification

Brand name(s): NIACIN
Generic name(s): NIACIN
Manufacturer(s): Lannett Company, Inc.
NDC(s): 62175-320, 62175-322
Route(s): ORAL

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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