FDA Drugs recall ·
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate… recall
- Recall number
- D-0670-2025
- Date
- (initiated August 28, 2025)
- Company / brand
- Granules Pharmaceuticals Inc.
3701 Concorde Pkwy, Chantilly, VA, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 11,895 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications:
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
lot#: GPC250159A, Exp Date: 06-22-2027
Distribution
Distributed Nationwide in the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0670-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.