Lannett recalls
FDA enforcement reports naming Lannett Company Inc. as the recalling firm.
- Recall reports
- 15
- Class I (serious)
- 1
- Most recent report
- Jul 8, 2026
- Jul 8, 2026Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulf…Drug · Lannett Company Inc.Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.Class II
- Jun 10, 2026Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed…Drug · Lannett Company Inc.Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.Class II
- May 27, 2026Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Compan…Drug · Lannett Company Inc.Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Class III
- Oct 29, 2025Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distrib…Drug · Lannett Company Inc.Failed Dissolution SpecificationsClass II
- Sep 17, 2025Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amph…Drug · Lannett Company Inc.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 Dex…Class II
- Sep 3, 2025Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by…Drug · Lannett Company Inc.Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.Class II
- Dec 11, 2024Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distribu…Drug · Lannett Company Inc.Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.Class II
- Jan 25, 2023Triamterene and Hydrochlorothiazide Capsules, USP (37Drug · Lannett Company Inc.Failed Impurity/Degradation SpecificationsClass III
- Jan 25, 2023Triamterene and Hydrochlorothiazide Capsules, USP (37Drug · Lannett Company Inc.Failed Impurity/Degradation SpecificationsClass III
- Feb 23, 2022Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPE…Drug · Lannett Company, Inc.Failed Impurities/Degradation Specifications: Out of specification results for related substances.Class II
- Prednisone Tablets, USP 2
- Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl
- Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed…
- Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distribu…
- HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg…
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