Recall D-0672-2025

US Class III Ongoing · initiated 2025-08-28

Recalling firm

Granules Pharmaceuticals Inc., VA

Product

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:

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