Why it was recalled
Failed Dissolution Specifications
Product description
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Lot numbers, UPCs & expiration codes
Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026
Where it was sold
Nationwide in the USA
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-0096-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 10, 2025
- FDA report date
- Oct 29, 2025
- Quantity
- 46,848 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company Inc.
Original FDA data
Every field from FDA enforcement report D-0096-2026, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97778
- Address
- 1101 C Ave W
- Code information
- Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026
- Postal code
- 47274-3342
- Report date
- Oct 29, 2025
- Product type
- Drugs
- Recall number
- D-0096-2026
- Classification
- Class II
- Recalling firm
- Lannett Company Inc.
- Product quantity
- 46,848 90-count bottles
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 10, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 22, 2025