D-0670-2025 Class III Ongoing
FDA drug recall D-0670-2025 was initiated by Granules Pharmaceuticals Inc. on Aug 28, 2025 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: The recall status is ongoing. Affected quantity: 11,895 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 1, 2025
- Initiation Date
- Aug 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,895 bottles
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
Reason for Recall
Failed Impurities/Degradation Specifications:
Distribution Pattern
Distributed Nationwide in the USA
Code Information
lot#: GPC250159A, Exp Date: 06-22-2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0670-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026