Lannett Company, Inc.: Drug Recall

Recall #D-0558-2022 · 02/09/2022

Class II: Risk

Recall Details

Recall Number: D-0558-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Lannett Company, Inc.
Status: Terminated
Date Initiated: 02/09/2022
Location: Philadelphia, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,598 bottles

Reason for Recall

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

Product Description

Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.

Distribution Pattern

Product was distributed nationwide in the USA.

Other Recalls by Lannett Company, Inc.

Class II: Risk 10/10/2025

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

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

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

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

Failed Impurity/Degradation Specifications

View all recalls by Lannett Company, Inc. →

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.