Niacin Extended-release Tablets recall: Failed Dissolution
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Why was Niacin Extended-release Tablets recalled?
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 25282724A, Exp. Date 2027/01
- Product
- Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
- Recalling firm
- Lannett Company Inc.
- Quantity
- 3984 bottles
- Distribution
- Nationwide within the United States
- Recall date
- June 10, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)