Lannett Company Inc.
Lannett Company Inc. appears in FDA public data with 15 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 21 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0660-2026, Class II) was initiated on June 26, 2026.
Summary
- Total Recalls
- 15 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 21
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0660-2026 | Class II | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphe | June 26, 2026 |
| D-0584-2026 | Class II | Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett C | May 27, 2026 |
| D-0533-2026 | Class III | Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Phil | April 24, 2026 |
| D-0096-2026 | Class II | Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lann | October 10, 2025 |
| D-0642-2025 | Class II | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfa | August 19, 2025 |
| D-0599-2025 | Class II | Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Com | August 11, 2025 |
| D-0112-2025 | Class II | Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lanne | October 25, 2024 |
| D-0161-2023 | Class III | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules | November 9, 2022 |
| D-0160-2023 | Class III | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle | November 9, 2022 |
| D-0558-2022 | Class II | Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, D | February 9, 2022 |
| D-1508-2020 | Class II | Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philad | August 10, 2020 |
| D-0630-2020 | Class I | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett | December 6, 2019 |
| D-0309-2020 | Class II | Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett C | October 28, 2019 |
| D-0996-2019 | Class III | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lanne | February 21, 2019 |
| D-0083-2019 | Class II | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx | October 11, 2018 |