Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Am...
FDA Recall #D-0672-2025 — Class III — August 28, 2025
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
Reason for Recall
Failed Impurities/Degradation Specifications:
Recalling Firm
Granules Pharmaceuticals Inc. — Chantilly, VA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
11,909 bottles
Distribution
Distributed Nationwide in the USA
Code Information
Lot#: GPC250179A, Exp Date: 06-22-2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated