Lannett Company, Inc. recalled 46,848 bottles of NIACIN Extended-release Tablets, 1,000 mg, Rx Only, distributed nationwide. The product failed dissolution specifications. Patients and healthcare providers should stop using it immediately and await recall instructions.
Failed Dissolution Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Lannett Company Inc. or your healthcare provider for guidance. Notification method: Letter
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NIACIN Extended-release tablets are a prescription-grade form of vitamin B3 used to treat cholesterol and other conditions under medical supervision. The product discussed is 1,000 mg per tablet and distributed nationwide in 90-tablet bottles.
The dissolution failure means the tablet may not dissolve properly in the stomach, potentially reducing therapeutic effect and leading to ineffective treatment.
This recall is not stated as part of a broader industry pattern.
Consumers may require alternatives or adjustments to therapy. The recall impacts patients relying on prescribed Niacin ER without assurance of dissolution performance until guidance is provided.
Label on the bottle shows NDC, lot number, and expiration date. The official recall notice will provide refund or replacement instructions.
Refunds or replacements are typically processed within 4-8 weeks after proof of purchase or return is received.
Keep the original bottle, packaging, and recall notice. Photograph the label showing NDC, lot, and expiration. Save receipts and correspondence with the manufacturer.
NDC: 62175-322-46. Pack: 90 tablets per bottle. Quantity recalled: 46,848 bottles. Distribution: Nationwide in the USA. Sold as NIACIN Extended-release Tablets, 1,000 mg, Rx Only. Lot numbers and expirations include: 21264027A Exp 10/30/2025; 22266446A Exp 12/31/2025; 22266901A Exp 02/28/2026; 22267553A Exp 03/31/2026; 22267554A Exp 02/28/2026; 22267555A Exp 02/28/2026; 22267992A Exp 04/30/2026; 22267993A; 22267994A Exp 05/31/2026.
No injuries or incidents have been reported.
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