D-0673-2025 Class III Ongoing
FDA drug recall D-0673-2025 was initiated by Granules Pharmaceuticals Inc. on August 28, 2025 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: The recall status is ongoing. Affected quantity: 11,928 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 1, 2025
- Initiation Date
- August 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,928 bottles
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
Reason for Recall
Failed Impurities/Degradation Specifications:
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot#: GPC250181A, Exp Date: 06-19-2027