Lannett Niacin Extended-Release Tablets Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Lannett Company Inc. is recalling 3,984 bottles of Niacin Extended-release Tablets, USP, 1,000 mg due to failed dissolution specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 9, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Lannett Company Inc. initiated a voluntary recall of Niacin Extended-release Tablets after testing showed the product failed dissolution specifications during 12-month long-term stability testing, with out-of-specification low results for Stage 3 dissolution at the 24-hour timepoint.
Which Products Are Affected
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, NDC 62175-322-46. Lot #: 25282724A, Exp. Date 2027/01. A total of 3,984 bottles are affected. Distributed nationwide within the United States.
What You Should Do
Consumers should contact their physician or healthcare provider if they have questions about the affected product. The recalling firm is Lannett Company Inc., located at 1101 C Ave W, Seymour, IN 47274-3342.
Why This Matters
The recall involves a prescription drug distributed nationwide that did not meet dissolution specifications, classified as Class II by the FDA.
Source
FDA recall D-0584-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (981 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.