Niacin Extended-release Tablets recall
FDA recall D-0584-2026 · initiated May 27, 2026
Lannett Company Inc. recalled Niacin Extended-release Tablets in May 2026 — an FDA Class II recall (D-0584-2026) because Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3984 bottles
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.
- Recalling company
- Lannett
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 27, 2026
- FDA report date
- Jun 10, 2026
Frequently asked
- Was Niacin Extended-release Tablets recalled?
- Lannett Company Inc. recalled Niacin Extended-release Tablets in May 2026 — an FDA Class II recall (D-0584-2026) because Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Niacin Extended-release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0584-2026 was: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- Is a recalled Niacin Extended-release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Niacin Extended-release Tablets are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 25282724A, Exp. Date 2027/01. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0584-2026.