Seymour, IN, United States
Lannett Company Inc. recalls
14 recalls recorded since 2018, most recently on 26 June 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)4
Terminated or completed10
Class I (FDA)1
Ongoing Class II Drugs
- Recall started
- 26 June 2026
- Reason
- Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0660-2026
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelph
Ongoing Class II Drugs
- Recall started
- 27 May 2026
- Reason
- Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0584-2026
- Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Ongoing Class III Drugs
- Recall started
- 24 April 2026
- Reason
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0533-2026
- Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Ongoing Class II Drugs
- Recall started
- 10 October 2025
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0096-2026
- Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Completed Class II Drugs
- Recall started
- 19 August 2025
- Reason
- 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.
- Distribution
- OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0642-2025
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 05
Terminated Class II Drugs
- Recall started
- 11 August 2025
- Terminated
- 24 June 2026
- Reason
- Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0599-2025
- Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Terminated Class II Drugs
- Recall started
- 25 October 2024
- Terminated
- 27 June 2025
- Reason
- Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0112-2025
- Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Terminated Class III Drugs
- Recall started
- 9 November 2022
- Terminated
- 8 June 2023
- Reason
- Failed Impurity/Degradation Specifications
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0161-2023, D-0160-2023
- Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,00
- Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
Terminated Class II Drugs
- Recall started
- 9 February 2022
- Terminated
- 1 May 2023
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results for related substances.
- Distribution
- Product was distributed nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0558-2022
- 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.
Terminated Class II Drugs
- Recall started
- 10 August 2020
- Terminated
- 22 July 2022
- Reason
- Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1508-2020
- Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Te
Terminated Class I Drugs
- Recall started
- 6 December 2019
- Terminated
- 13 July 2020
- Reason
- Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0630-2020
- Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
Terminated Class II Drugs
- Recall started
- 28 October 2019
- Terminated
- 26 April 2021
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0309-2020
- Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
Terminated Class III Drugs
- Recall started
- 21 February 2019
- Terminated
- 6 November 2020
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide, including Puerto Rico.
- Initiated
- N/A
- Recall number
- D-0996-2019
- Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
Terminated Class II Drugs
- Recall started
- 11 October 2018
- Terminated
- 22 February 2019
- Reason
- CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0083-2019
- HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.