# FDA recall D-0584-2026

> **Lannett Company Inc.** · Class II · drug recall initiated 2026-05-27.

## 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.

## Reason for recall

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0584-2026
- **Recalling firm:** Lannett Company Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-05-27
- **Report date:** 2026-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seymour, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0584-2026

## Citation

> MORVS. FDA recall D-0584-2026. Retrieved 2026-10-22 from https://api.morvs.ai/recall/D-0584-2026. Source: US FDA. Licensed CC0.

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