FDA recall, , Moderate risk
Lannett Niacin Extended-Release Tablets
Niacin Extended-release Tablets failed dissolution specifications during stability testing.
Summary by Recall Canary from the FDA notice
What happened
Lannett Company Inc., of Seymour, Indiana, recalled Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, because the product failed dissolution specifications during stability testing, with an out-of-specification low for Stage 3 dissolution at the 24-hour timepoint. The company began the recall on May 27, 2026, and the FDA added it to the Enforcement Report on June 3, 2026, with classification on June 10, 2026.
The recalled tablets were distributed nationwide within the United States. The product is identified as Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, distributed by Lannett Company, Inc., Philadelphia, PA 19136. The recall involves 3,984 bottles.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles
- NDC
- 62175-322-46
- Lot code
- 25282724A
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Lannett Company Inc.Seymour, Indiana
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99107
- Recall number
- D-0584-2026
- Quantity recalled
- 3984 bottles
All recalls from Lannett Company Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA · In FDA's weekly enforcement report
Summary updated
