Granules Pharmaceuticals Inc.: Drug Recall
Recall #D-0669-2025 · 08/28/2025
Class III: Low Risk
Recall Details
- Recall Number
- D-0669-2025
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Granules Pharmaceuticals Inc.
- Status
- Ongoing
- Date Initiated
- 08/28/2025
- Location
- Chantilly, VA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,384 bottles
Reason for Recall
Failed Impurities/Degradation Specifications:
Product Description
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
Distribution Pattern
Distributed Nationwide in the USA
Other Recalls by Granules Pharmaceuticals Inc.
- Class II: Risk 01/26/2026
- Class III: Low Risk 08/28/2025
- Class III: Low Risk 08/28/2025
- Class III: Low Risk 08/28/2025
- Class III: Low Risk 08/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.