Lannett Company, Inc.
Overview
Lannett Company, Inc. is a pharmaceutical company that develops, manufactures, and sells generic medications. The company focuses on producing affordable alternatives to branded drugs, covering a range of therapeutic areas. Lannett is committed to delivering quality health products while fostering innovation in the pharmaceutical industry.
API / Drug Master Files
Lannett Company, Inc. holds 0 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.Inactive1970-11-24
FDA compliance signals
23 FDA enforcement records linked to this company.
- recall — Class II2026-06-10
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- recall — Class III2026-05-27
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- recall — Class II2025-10-29
Failed Dissolution Specifications
- recall — Class II2025-09-17
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
- recall — Class II2025-09-03
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
- recall — Class II2024-12-11
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- recall — Class III2023-01-25
Failed Impurity/Degradation Specifications
- recall — Class III2023-01-25
Failed Impurity/Degradation Specifications
- recall — Class II2022-02-23
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
- recall — Class II2020-08-26
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
- recall — Class I2019-12-25
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
- recall — Class II2019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
- recall — Class III2019-03-20
Failed Dissolution Specifications
- recall — Class II2018-10-31
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
- 4832018-02-02
Batch production and Batch Control Record Requirements
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