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), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
- UPC
- 0370010029019
- Lot code
- GPC250179A
Additional details
Lot#: GPC250179A, Exp Date: 06-22-2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 11,909 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.