Granules Pharmaceuticals Inc. recalls Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Ext…
- Recall date
- August 28, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0669-2025
- FDA classification
- Class III
- Brand / firm
- Granules Pharmaceuticals Inc.
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
Failed Impurities/Degradation Specifications:
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
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