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.

FDA recall notice · announced June 10, 2026 · Lannett

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 25282724A, Exp. Date 2027/01
Quantity: 3984 bottles
Status: Ongoing
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.