FDAClass IIIOctober 1, 2025

Dextroamphetamine Saccharate recall: Impurity Out of Spec

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed…

Why was Dextroamphetamine Saccharate recalled?

Failed Impurities/Degradation Specifications:

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: GPC250181A, Exp Date: 06-19-2027

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed…
Recalling firm
Granules Pharmaceuticals Inc.
Quantity
11,928 bottles
Distribution
Distributed Nationwide in the USA
Recall date
October 1, 2025
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls