FDA·Medicines·October 29, 2025

Lannett recalls Niacin Extended-release Tablets, USP, 1,000 mg because they failed dissolution specifications

The recalled 90-count bottles of Niacin Extended-release Tablets, USP, 1,000 mg failed dissolution specifications, and the notice does not say what this could do to a person.

What to do

The notice does not give instructions. Read the official notice for details.

Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.

Recall details

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
Hazard
Failed Dissolution Specifications
Units
46,848 90-count bottles
Where sold
Nationwide in the USA
FDA classification
Class II · Ongoing
Classified by FDA
October 22, 2025
Recall started
October 10, 2025
FDA enforcement report
October 29, 2025
Identifiers
  • 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
  • FDA recall number: D-0096-2026

The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.

Official notice

The notice's own wording from FDA.

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
Reason for recall
Failed Dissolution Specifications
Classification
Class II (Ongoing)
Distribution
Nationwide in the USA
Quantity
46,848 90-count bottles

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