Dextroamphetamine Saccharate — Class III drug recall D-0669-2025
Ongoing recall by Granules Pharmaceuticals Inc., reported 2025-10-01, distributed nationwide. Failed Impurities/Degradation Specifications:
| Recall number | D-0669-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules Pharmaceuticals Inc., Chantilly, VA, United States |
| Recall initiated | 2025-08-28 |
| Classified | 2025-09-24 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 3,384 bottles |
| Reason classes | specification failure |
| NDC | 70010-0029, 70010-0029-01, 70010-0030, 70010-0030-01, 70010-0031, 70010-0031-01, 70010-0032, 70010-0032-01, 70010-0033, 70010-0033-01, 70010-0034, 70010-0034-01 |
| Lot numbers | GPC250158A |
| Expiration dates | 2027-06-22 |
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 for recall
Failed Impurities/Degradation Specifications:
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-0669-2025. 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.