Recalls / Class II
Class IID-0096-2026
Product
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
- Brand name
- Niacin
- Generic name
- Niacin
- Active ingredient
- Niacin
- Route
- Oral
- NDCs
- 62175-320, 62175-322
- FDA application
- ANDA203899
- Affected lot / code info
- 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
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Lannett Company Inc.
- Manufacturer
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1101 C Ave W, Seymour, Indiana 47274-3342
Distribution
- Quantity
- 46,848 90-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-10-10
- FDA classified
- 2025-10-22
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0096-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.