Lannett niacin extended-release tablets failed dissolution specifications during stability
Lannett Niacin Extended-release Tablets, 1,000 mg, are being recalled after a stability test returned an out-of-specification low result for Stage 3 dissolution at 24 hours.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a failed dissolution specification, which can alter the rate of drug release and creates a risk of harm with no injuries reported.
Plain-English summary
Niacin Extended-release Tablets, USP, 1,000 mg, in 90-count bottles, distributed by Lannett Company, Inc. of Philadelphia, NDC 62175-322-46, are being recalled. The action covers 3,984 bottles.
The stated reason is failed dissolution specifications: during 12-month long-term stability testing the product was out of specification, low, for Stage 3 dissolution at the 24-hour timepoint. Dissolution testing measures how a tablet releases its active ingredient over time, which matters particularly for an extended-release formulation. The FDA classified the action as Class II.
The affected lot is 25282724A, expiry 2027/01. Distribution was nationwide within the United States.
This is a prescription medicine. Patients should not stop taking a prescribed course without medical advice; anyone holding the affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- Lannett Company Inc.
- Category
- Drug — Extended-release tablet
- Hazard
- failed-dissolution
- extended-release
- stability-testing
- class-ii
- prescription-drug
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 (2)
- Lot #: 25282724A
- Exp. Date 2027/01
UPCs (1)
- 0362175320469
Distribution
Distributed nationwide across the United States.
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