Drug 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

D-0096-2026

October 10, 2025

Class II

Product summary

Firm: Lannett Company Inc.
Event: Event 97778
Status: Ongoing
Classification: Class II
Quantity: 46,848 90-count bottles
Official record key: drug-enforcement:D-0096-2026

Official wording

Reason: Failed Dissolution Specifications

Code information: 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

Distribution pattern: Nationwide in the USA

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications