FDA Drug recall D-0669-2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsul…
- FDA Drug
- Class III
- ongoing
- Published 2025-10-01
On 2025-10-01 the FDA classified a Class III recall of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsul… by Granules Pharmaceuticals, citing failed Impurities/Degradation Specifications:.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0669-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-08-28 |
| Published | 2025-10-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Granules Pharmaceuticals |
| Distribution | US |
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
Reason
Failed Impurities/Degradation Specifications:
Identifiers
| ndc | 70010-029-01 |
|---|---|
| ndc | 70010-030-01 |
| ndc | 70010-031-01 |
| ndc | 70010-032-01 |
| ndc | 70010-033-01 |
| ndc | 70010-034-01 |
| code_info | Lot#: GPC250158A, Exp Date: 06-22-2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0669-2025%22
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