Drug Recall: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10
Granules Pharmaceuticals Inc. · August 28, 2025
Reason for Recall
Failed Impurities/Degradation Specifications:
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
Distribution
Distributed Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
11,895 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0670-2025
Status: ongoing
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