Lannett Company recalls 1,000 mg niacin extended-release tablets (Rx only) due to failed dissolution specifications. This may affect safety in normal use. Check NDC and lot numbers for affected batches.
“Lannett Niacin Extended-release Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31719-lannett-niacin-extended-release-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0096-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2026%22&limit=1).
The FDA announced on Oct. 10, 2025, that Lannett Company Inc. is voluntarily recalling Niacin Extended-release Tablets, USP, 1,000 mg due to failed dissolution specifications. Owners should contact the company for a refund.
The tablets failed dissolution specifications, meaning they may not release the medication as intended. The FDA's FAERS database contains 11,500 adverse-event reports naming this product, including 6,471 marked serious and 756 listing a death, though these are unverified reports.
Context
GovInfoNow's records show Lannett Company Inc. has had 13 other recalls on record since Oct. 11, 2018. Other recent recalls of similar products include Dextroamphetamine Extended-Release Capsules (June 26, 2026), Primidone Tablets (April 24, 2026), and another Niacin recall by Lannett (May 27, 2026). Other recent recalls of similar products include Golden State NIACIN Extended-Release Tablets (May 29, 2026), Golden State Recalls Niacin 1000mg (Oct. 20, 2025), and Ajanta Pharma Recalls Ranolazine 1000mg (Sept. 17, 2026).
How to tell if you have this one
Check the NDC code (62175-322-46) and lot numbers listed: 21264027A (exp 10/30/2025), 22266446A (exp 12/31/2025), and other specific lots with their expiration dates.
Brand
Lannett
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 62175-322-46 and lot numbers listed in the recall to identify affected tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0096-2026 (October 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0096-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.