Lannett recalls Niacin Extended-release Tablets 1,000 mg over failed dissolution test
During stability testing, the tablets failed a dissolution test at the 24-hour timepoint, with results coming in too low, so they did not meet the required release specifications.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Company
- Lannett Company Inc.
- Hazard
- Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- Units
- 3984 bottles
- Where sold
- Nationwide within the United States
- FDA classification
- Class II · Ongoing
- Classified by FDA
- June 10, 2026
- Recall started
- May 27, 2026
- FDA enforcement report
- June 10, 2026
- Identifiers
- Codes: Lot #: 25282724A, Exp. Date 2027/01
- FDA recall number: D-0584-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 3984 bottles
Related recalls
Lannett recalls Niacin Extended-release Tablets, USP, 1,000 mg because they failed dissolution specifications
The recalled 90-count bottles of Niacin Extended-release Tablets, USP, 1,000 mg failed dissolution specifications, and the notice does not say what this could do to a person.
Lannett Company Inc. · 46,848 90-count bottles
Golden State Medical Supply recalls niacin extended-release tablets because they failed a dissolution test
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