Skip to content
Back to recalls
Drug FDA Class II Ongoing Failed specifications

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.

Lannett Company Inc. Published Jun 10, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lannett Company Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Dissolution · primary

Affected products (1)

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.

NIACIN · 3984 bottles

NDC: 62175-320, 62175-322, 62175-320-46, 62175-320-43, 62175-322-46, 62175-322-43
Code info: Lot #: 25282724A, Exp. Date 2027/01

Affected areas

Nationwide

Timeline

  1. Initiated
    May 27, 2026
  2. Published
    Jun 10, 2026
Recall number
D-0584-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.