D-0673-2025 Class III Ongoing

Recalled by Granules Pharmaceuticals Inc. — Chantilly, VA

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