FDA Recall D-0669-2025

Granules Pharmaceuticals Inc. · Chantilly, VA

Class III Ongoing 259 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot#: GPC250158A, Exp Date: 06-22-2027

Quantity: 3,384 bottles

Reason for recall

Failed Impurities/Degradation Specifications:

Recall record

Recall number: D-0669-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Distributed Nationwide in the USA
Recall initiated: 2025-08-28
Classified by FDA Center: 2025-09-24
FDA published: 2025-10-01
Recalling firm: Granules Pharmaceuticals Inc.
Firm location: Chantilly, VA

Drug identification

Brand name(s): DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Generic name(s): DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer(s): Granules Pharmaceuticals Inc.
NDC(s): 70010-029, 70010-030, 70010-031, 70010-032, 70010-033, 70010-034
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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