FDA Drug recall D-0642-2025
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottl…
- FDA Drug
- Class II
- completed
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottl… by Lannett, citing presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0642-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-08-19 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | OH |
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-0762-37.
Reason
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Identifiers
| ndc | 0527-0760-37 |
|---|---|
| ndc | 0527-0761-37 |
| ndc | 0527-0762-37 |
| ndc | 0527-0763-37 |
| ndc | 0527-0764-37 |
| ndc | 0527-0765-37 |
| ndc | 0527-0766-37 |
| code_info | Lot#: 25283185A. Expiry: 02/28/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Other recalls by Lannett
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsule…
FDA Drug · Class II · 2026-07-08 · Lannett - Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, N…
FDA Drug · Class II · 2026-06-10 · Lannett - Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01
FDA Drug · Class III · 2026-05-27 · Lannett - Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 191…
FDA Drug · Class II · 2025-10-29 · Lannett - Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136
FDA Drug · Class II · 2025-09-03 · Lannett
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0642-2025%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.