Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Reported: October 1, 2025 Initiated: August 28, 2025 #D-0671-2025
Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Reason for Recall
Failed Impurities/Degradation Specifications:
Details
- Recalling Firm
- Granules Pharmaceuticals Inc.
- Units Affected
- 9,917 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Chantilly, VA
Frequently Asked Questions
What product was recalled? ▼
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01. Recalled by Granules Pharmaceuticals Inc.. Units affected: 9,917 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 1, 2025. Severity: Low. Recall number: D-0671-2025.
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