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Class II · ModerateActive recall

Niacin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 25282724A, Exp. Date 2027/01
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLannett Company, Inc.
Brand nameNIACIN
Generic nameNIACIN
Active ingredient(s)NIACIN
Distributed by / forLannett Company, Inc., Philadelphia, PA 19136
NDC62175-322-46
Show the full FDA record
Full product labelNiacin 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 firmLannett Company Inc.
DistributionNationwide within the United States
Quantity3984 bottles
Recall initiated2026-05-27
Report date2026-06-10
Recall completed—
Recall numberD-0584-2026
ClassificationClass II
FDA statusOngoing
Origin on fileSeymour IN United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.