Lannett Company, Inc.

FDA Regulatory Profile

Summary

Total Recalls
12 (1 Class I)
510(k) Clearances
0
Inspections
21
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0096-2026Class IINiacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: LannOctober 10, 2025
D-0642-2025Class IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfaAugust 19, 2025
D-0599-2025Class IILisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett ComAugust 11, 2025
D-0112-2025Class IILisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: LanneOctober 25, 2024
D-0161-2023Class IIITriamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules November 9, 2022
D-0160-2023Class IIITriamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottleNovember 9, 2022
D-0558-2022Class IIDiazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, DFebruary 9, 2022
D-1508-2020Class IIPrednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., PhiladAugust 10, 2020
D-0630-2020Class ILevetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett December 6, 2019
D-0309-2020Class IILannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett COctober 28, 2019
D-0996-2019Class IIIOxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: LanneFebruary 21, 2019
D-0083-2019Class IIHydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx October 11, 2018