Lisdexamfetamine Dimesylate Capsules — Class II drug recall D-0112-2025
Terminated recall by Lannett Company Inc., reported 2024-12-11, distributed nationwide. Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content unif
| Recall number | D-0112-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company Inc., Seymour, IN, United States |
| Recall initiated | 2024-10-25 |
| Classified | 2024-12-05 |
| Reported by FDA | 2024-12-11 |
| Terminated | 2025-06-27 |
| Distributed | Nationwide (US) |
| Quantity | 1,608 bottles |
| NDC | 00527-4661-37 |
| Lot numbers | 23274856A |
| Expiration dates | 2025-04-30 |
Product
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Reason for recall
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
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-0112-2025. 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.