Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte
Summary
The FDA issued a Class III for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetami by Granules Pharmaceuticals Inc.. Reason: Failed Impurities/Degradation Specifications:.
Details
Source
Drug Recall
External ID
D-0672-2025
Action Date
2025-10-01
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: GPC250179A, Exp Date: 06-22-2027
Quantity Affected: 11,909 bottles
Reason for Recall
Failed Impurities/Degradation Specifications:
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-28
Company
Chantilly, VA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 70 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Granules Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Granules Pharmaceuticals Inc. have FDA actions?
Granules Pharmaceuticals Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0672-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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