Lisdexamfetamine Dimesylate Capsules — Class II drug recall D-0599-2025
Terminated recall by Lannett Company Inc., reported 2025-09-03, distributed nationwide. Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphet
| Recall number | D-0599-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company Inc., Seymour, IN, United States |
| Recall initiated | 2025-08-11 |
| Classified | 2025-08-25 |
| Reported by FDA | 2025-09-03 |
| Terminated | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 8,544 bottles |
| Reason classes | labeling |
| NDC | 00527-4664-37 |
| Lot numbers | 25280726A |
| Expiration dates | 2027-03 |
Product
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Reason for recall
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0599-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.