Niacin extended release tablets recalled after failing dissolution specifications
Lannett is recalling 46,848 bottles of Niacin Extended-release Tablets USP 1,000 mg across several lots for failed dissolution specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a specification failure: the record states only that dissolution specifications were not met, without describing a health consequence or reporting injury.
Plain-English summary
Niacin Extended-release Tablets, USP, 1,000 mg, 90 tablets per bottle, distributed by Lannett Company of Philadelphia, Pennsylvania, are being recalled for failed dissolution specifications.
The recall covers 46,848 bottles from lots including 21264027A (expiring 30 October 2025), 22266446A (expiring 31 December 2025) and 22266901A (expiring 28 February 2026), carrying NDC 62175-322-46. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the dissolution failure without describing a health consequence, and reports no injuries.
This is a prescription medicine, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Lipid modifying agent
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lot
- expiry: 21264027A
- Exp 10/30/2025
- 22266446A
- Exp 12/31/2025
- 22266901A
- Exp 02/28/2026
- 22267553A
- 22267554A
- Exp 03/31/2026
- 22267555A
- 22267992A
- Exp 04/30/2026
- 22267993A
- 22267994A
- Exp 05/31/2026
UPCs (1)
- 0362175320469
Distribution
Distributed nationwide across the United States.
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