← FDA ENFORCEMENT
D-0672-2025Class III

Granules Pharmaceuticals Inc.

Recalling firm
Granules Pharmaceuticals Inc.
Product type
Drug
Status
Ongoing
Report date
2025-10-01
Distribution
Distributed Nationwide in the USA
Firm state
VA
Product quantity
11,909 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01

Code / lot info

Lot#: GPC250179A, Exp Date: 06-22-2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.