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FDA · Drugs ·

Niacin Extended-release Tablets recall

Lannett Company Inc. recalled Niacin Extended-release Tablets on June 10, 2026 because of failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. It was sold nationwide.

Why it was recalled

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

What's recalled

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.

Quantity: 3984 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Lannett Company Inc., Seymour, IN
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the United States
Status
Ongoing
Recall number
D-0584-2026
Source
U.S. Food and Drug Administration

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