FDA recall D-0669-2025

Granules Pharmaceuticals Inc. · Class III · drug

Product

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

Reason for recall

Failed Impurities/Degradation Specifications:

Distribution

Distributed Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-08-28
Report date
2025-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chantilly, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0669-2025