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Recall Observatory FDA recall evidence

Drug product

Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.

D-0584-2026

May 27, 2026

Class II

Product summary

Firm
Lannett Company Inc.
Event
Event 99107
Status
Ongoing
Classification
Class II
Quantity
3984 bottles
Official record key
drug-enforcement:D-0584-2026

Official wording

Reason: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

Code information: Lot #: 25282724A, Exp. Date 2027/01

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications