Prescription Niacin Tablets Recalled for Failed Dissolution Specifications
Lannett Company is recalling prescription niacin extended-release tablets nationwide due to failed dissolution specifications. Affected tablets may not release medication properly.
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: This is an FDA Class II recall with no reported illnesses or injuries. Failed dissolution specifications represent a manufacturing quality defect that could reduce therapeutic effectiveness, but the hazard is loss of efficacy rather than direct safety risk.
Plain-English summary
Lannett Company Inc. is recalling Niacin Extended-release Tablets, USP, 1,000 mg (Rx Only) due to failed dissolution specifications. The affected products consist of 46,848 bottles containing 90 tablets each, distributed nationwide in the United States.
Eight specific lots are affected, with expiration dates ranging from October 2025 through May 2026. Tablets that fail to meet dissolution specifications may not release the active ingredient properly, reducing the medication's therapeutic effectiveness.
Patients currently taking affected lots should contact their pharmacist or healthcare provider immediately. Do not stop taking niacin therapy without medical guidance. Consumers who have purchased this product should verify their lot number against the recall information and consult their healthcare provider about alternative medications or continuation of therapy as appropriate.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- Lannett Company Inc.
- Category
- Drug
- Hazard
- failed-dissolution
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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