Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philad
Summary
The FDA issued a Class II for Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distr by Lannett Company Inc.. Reason: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint..
Details
Source
Drug Recall
External ID
D-0584-2026
Action Date
2026-06-10
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: 25282724A, Exp. Date 2027/01
Quantity Affected: 3984 bottles
Reason for Recall
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-27
Company
Seymour, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lannett Company Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lannett Company Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lannett Company Inc. have FDA actions?
Lannett Company Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0584-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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