Recalls / Class III
Class IIID-0670-2025
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
- Brand name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate
- Active ingredients
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 70010-029, 70010-030, 70010-031, 70010-032, 70010-033, 70010-034
- FDA application
- ANDA217027
- Affected lot / code info
- lot#: GPC250159A, Exp Date: 06-22-2027
Why it was recalled
Failed Impurities/Degradation Specifications:
Recalling firm
- Firm
- Granules Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 3701 Concorde Pkwy, N/A, Chantilly, Virginia 20151-1126
Distribution
- Quantity
- 11,895 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-08-28
- FDA classified
- 2025-09-24
- Posted by FDA
- 2025-10-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0670-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.