FDAHealthAugust 28, 2025
Granules Pharmaceuticals Inc. — Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single
⚠️ Failed Impurities/Degradation Specifications:
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 28, 2025
Distributed Nationwide in the USA
What's affected?
- Product
- 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
- UPC
- 0370010029019
- Lot code
- GPC250159A
Additional details
lot#: GPC250159A, Exp Date: 06-22-2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 11,895 bottles.
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