Lannett recalls
Lannett appears in 15 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 15 |
|---|---|
| Published | 2018-10-31 to 2026-07-08 |
| By agency | FDA Drug (15) |
| By classification | Class II (10), Class III (4), Class I (1) |
| By status | terminated (10), ongoing (4), completed (1) |
| Distribution named in notices | OH, US |
Recalls
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsule…
FDA Drug · Class II · 2026-07-08 · Lannett
Reason: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. - Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, N…
FDA Drug · Class II · 2026-06-10 · Lannett
Reason: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. - Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01
FDA Drug · Class III · 2026-05-27 · Lannett
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. - Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 191…
FDA Drug · Class II · 2025-10-29 · Lannett
Reason: Failed Dissolution Specifications - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottl…
FDA Drug · Class II · 2025-09-17 · Lannett
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 Dex… - Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136
FDA Drug · Class II · 2025-09-03 · Lannett
Reason: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. - Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC:…
FDA Drug · Class II · 2024-12-11 · Lannett
Reason: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. - Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc.…
FDA Drug · Class III · 2023-01-25 · Lannett
Reason: Failed Impurity/Degradation Specifications - Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Com…
FDA Drug · Class III · 2023-01-25 · Lannett
Reason: Failed Impurity/Degradation Specifications - Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., P…
FDA Drug · Class II · 2022-02-23 · Lannett
Reason: Failed Impurities/Degradation Specifications: Out of specification results for related substances. - Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianj…
FDA Drug · Class II · 2020-08-26 · Lannett
Reason: Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg - Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc
FDA Drug · Class I · 2019-12-25 · Lannett
Reason: Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count. - Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc
FDA Drug · Class II · 2019-11-20 · Lannett
Reason: CGMP Deviations: Presence of NDMA impurity detected in product. - Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154…
FDA Drug · Class III · 2019-03-20 · Lannett
Reason: Failed Dissolution Specifications - HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, In…
FDA Drug · Class II · 2018-10-31 · Lannett
Reason: CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.