FDA Drug recall D-0599-2025
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136
- FDA Drug
- Class II
- terminated
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136 by Lannett, citing labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0599-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-08-11 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
Product
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Reason
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Identifiers
| ndc | 0527-4661-37 |
|---|---|
| ndc | 0527-4662-37 |
| ndc | 0527-4663-37 |
| ndc | 0527-4664-37 |
| ndc | 0527-4665-37 |
| ndc | 0527-4666-37 |
| ndc | 0527-4667-37 |
| code_info | Lot #: 25280726A, Exp. Date 03/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0599-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.