Lannett Niacin Extended-release Tablets Recall: Failed Dissolution Testing
Lannett recalls 1,000 mg niacin extended-release tablets due to failed dissolution testing. This may affect medication effectiveness. Contact Lannett for details.
Lower-risk recall
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Contact the company
What happened, in plain English
Lannett is recalling 1,000 mg niacin extended-release tablets that failed dissolution testing. This could mean the medication doesn't work as intended, so affected users should check their prescription details. Read more at govinfonow.com/recall/31287-lannett-niacin-extended-release-tablets-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/31287-lannett-niacin-extended-release-tablets-recall-failed-dissolution-testing · Updated August 10, 2026 · FDA enforcement record: FDA #D-0584-2026
Cite this page
“Lannett Niacin Extended-release Tablets Recall: Failed Dissolution Testing.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31287-lannett-niacin-extended-release-tablets-recall-failed-dissolution-testing. Based on FDA recall #D-0584-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0584-2026%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing during stability checks, meaning they may not release niacin properly over time. This could lead to inconsistent medication effectiveness rather than immediate harm.
Who’s affected
Prescription users of Lannett's 1,000 mg niacin extended-release tablets. Those with a prescription for this specific product are most at risk.
How to tell if you have this one
Check for the 90-count bottles labeled 'Niacin Extended-release Tablets, USP, 1,000 mg' with NDC 62175-322-46. The lot number 25282724A was distributed by Lannett Company, Inc. in Philadelphia, PA.
- Brand
Lannett- Category
Drug
What to do — step by step
Check Prescription Details
Verify if your prescription matches the recalled product: 1,000 mg niacin extended-release tablets, 90-count bottles, Rx only.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 14 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0584-2026 (May 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0584-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.