Class III
Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
This recall is currently active, issued October 1, 2025. It was issued by Granules Pharmaceuticals Inc..
- Company
- Granules Pharmaceuticals Inc.
- Recall Initiated
- August 28, 2025
- Posted
- October 1, 2025
- Recall Number
- D-0671-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,917 bottles
- Firm Location
- Chantilly, VA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications:
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot#: GPC250178A, Exp Date: 06-22-2027
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