Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.
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
The recalled product is Niacin Extended-release Tablets, USP, 1,000 mg, distributed by Lannett Company, Inc. Each bottle contains 90 tablets. The affected lot numbers include 21264027A, 22266446A, 22266901A, and more with various expiration dates.
The product failed to meet dissolution specifications. This could lead to insufficient medication release, reducing its effectiveness in managing cholesterol levels.
No specific incidents or injuries have been reported due to this recall. The classification is considered Class II due to potential health risks.
Stop using the recalled Niacin tablets immediately. Contact Lannett Company, Inc. or your healthcare provider for further instructions and to discuss alternative treatments.
For more information, contact Lannett Company, Inc. at their Philadelphia office or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0096-2026.
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