Niacin Extended-release Tablets recall
FDA recall D-0096-2026 · initiated Oct 10, 2025
Lannett Company Inc. recalled Niacin Extended-release Tablets in Oct 2025 — an FDA Class II recall (D-0096-2026) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
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: 46,848 90-count bottles
Details
- Product
- Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, 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 in the USA
- Initiated
- Oct 10, 2025
- FDA report date
- Oct 29, 2025
Frequently asked
- Was Niacin Extended-release Tablets recalled?
- Lannett Company Inc. recalled Niacin Extended-release Tablets in Oct 2025 — an FDA Class II recall (D-0096-2026) because Failed Dissolution Specifications. 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-0096-2026 was: Failed Dissolution Specifications
- 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 in the USA. The recall covers these lots — Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026. 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-0096-2026.