FDA Recalls Dextroamphetamine Extended-Release Capsules for Failed Purity Specifications
Granules Pharmaceuticals is recalling 11,895 bottles of 10 mg Dextroamphetamine Extended-Release Capsules due to failed impurity and degradation testing. The affected lot was 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: Class III recall with no reported illnesses or injuries. The hazard is specification failure—impurities and degradation—without known adverse events. Per the rubric, theoretical hazards without reported harm in Class III recalls typically score 2 (Moderate).
Plain-English summary
Granules Pharmaceuticals Inc. is recalling 11,895 bottles of Dextroamphetamine Extended-Release Capsules, 10 mg. The affected lot (GPC250159A, expiration 06-22-2027) was distributed nationwide throughout the USA.
The recall was initiated due to failed impurity and degradation specifications. Testing identified that the product did not meet established quality and purity standards.
Consumers who have this medication should check their pharmacy bottle for lot number GPC250159A. The FDA classified this as a Class III recall.
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 — Prescription Amphetamine
- 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#: GPC250159A
- Exp Date: 06-22-2027
UPCs (6)
- 0370010029019
- 0370010030015
- 0370010032019
- 0370010034013
- 0370010031012
- 0370010033016
Distribution
Distributed nationwide across the United States.
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