Lannett Company Inc.

7 FDA enforcement actions

7 Total Recalls

0 Class I

5 Class II

2 Class III

Firm Details

Product Types: drug
States: IN, PA

All Recalls

Class II: Risk 10/10/2025 drug

Failed Dissolution Specifications
Class II: Risk 08/19/2025 drug

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.
Class II: Risk 08/11/2025 drug

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Class II: Risk 10/25/2024 drug

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class III: Low Risk 11/09/2022 drug

Failed Impurity/Degradation Specifications
Class III: Low Risk 11/09/2022 drug

Failed Impurity/Degradation Specifications
Class II: Risk 02/09/2022 drug

Failed Impurities/Degradation Specifications: Out of specification results for related substances.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.