Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte
Recalled October 1, 2025 · FDA recall D-0671-2025 · Granules Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: · FDA Class III
Units
9,917 bottles
Sold at
Distributed Nationwide in the USA
Description
Failed Impurities/Degradation Specifications:
Product
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
Manufacturer(s)
Granules Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →