FDA Drug recall D-0112-2025
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC:…
- FDA Drug
- Class II
- terminated
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC:… by Lannett, citing failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0112-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-10-25 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
Product
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Reason
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
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: 23274856A, Exp 04/30/2025 |
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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FDA Drug · Class II · 2025-10-29 · Lannett - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottl…
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2025%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.