Lannett Company Inc.

Complete recall history across all FDA and CPSC categories — 7 total recalls

Lannett Company Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (7)

FDA drug safety enforcement actions by Lannett Company Inc.

Date Product Reason Class
Oct 10, 2025 Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottl... Failed Dissolution Specifications Class II
Aug 19, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetam... Class II
Aug 11, 2025 Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist... Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Caps... Class II
Oct 25, 2024 Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only... Failed Content Uniformity Specifications: Product failed to meet the action l... Class II
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... Failed Impurity/Degradation Specifications Class III
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [... Failed Impurity/Degradation Specifications Class III
Feb 21, 2019 Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... Failed Dissolution Specifications Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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