FDAFDA · Food and drugs·Recall number D-0669-2025
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
Published October 1, 2025 · Recall initiated: August 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Granules Pharmaceuticals Inc.
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0370010029019
- Lot
- Lot#: GPC250158A, Exp Date: 06-22-2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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