FDA Recalls Amphetamine Extended-Release Capsules for Failed Specifications
Granules Pharmaceuticals is recalling 11,909 bottles of dextroamphetamine/amphetamine extended-release capsules (20 mg) due to failed impurity and degradation specifications. The recall affects products distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The issue involves failed impurity and degradation specifications in a controlled substance formulation, which warrants precautionary action but does not indicate actual patient harm.
Plain-English summary
Granules Pharmaceuticals Inc. is recalling 11,909 bottles of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, 20 mg (NDC 70010-032-01). The affected lot number is GPC250179A with an expiration date of June 22, 2027.
The recall was initiated due to failed impurity and degradation specifications. This is an FDA Class III recall.
The affected product was distributed nationwide in the United States. The medication is intended for oral use. The FDA recall number for this action is D-0672-2025.
The recalled product
- Product
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
- Brand
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Manufacturer
- Granules Pharmaceuticals Inc.
- Category
- Drug
- Hazard
- impurity
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: GPC250179A
- Exp Date: 06-22-2027
UPCs (6)
- 0370010029019
- 0370010030015
- 0370010032019
- 0370010034013
- 0370010031012
- 0370010033016
Distribution
Distributed nationwide across the United States.
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Same brand · DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
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