Why it was recalled
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Product description
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Lot numbers, UPCs & expiration codes
Lot #: 25282724A, Exp. Date 2027/01
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0584-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 27, 2026
- FDA report date
- Jun 10, 2026
- Quantity
- 3984 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0584-2026, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Ongoing
- Country
- United States
- Event ID
- 99107
- Address
- 1101 C Ave W
- Code information
- Lot #: 25282724A, Exp. Date 2027/01
- Postal code
- 47274-3342
- Report date
- Jun 10, 2026
- Product type
- Drugs
- Recall number
- D-0584-2026
- Classification
- Class II
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 3984 bottles
- Reason for recall
- Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 27, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2026