Prescription Amphetamine Extended-Release Capsules Recalled for Failed Quality Specifications
Granules Pharmaceuticals Inc. is recalling 3,384 bottles of amphetamine extended-release capsules nationwide due to failed impurity and degradation specifications. No illnesses have been reported.
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 drug recall with no reported illnesses, injuries, or adverse effects. The hazard involves failed product specifications related to impurities and degradation, which are quality-control issues rather than documented safety threats. Per the severity rubric, Class III recalls without reported harm typically score 1 or 2; this scores as Moderate because it involves a controlled pharmaceutical where product quality is critical.
Plain-English summary
Granules Pharmaceuticals Inc. is recalling 3,384 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate extended-release capsules, 5 mg, due to failed impurity and degradation specifications. The affected lot number is GPC250158A, with an expiration date of June 22, 2027.
The product was distributed nationwide throughout the United States. The recall affects multiple NDC codes: 70010-029-01, 70010-030-01, 70010-031-01, 70010-032-01, 70010-033-01, and 70010-034-01.
Patients currently taking this medication should consult their healthcare provider or pharmacist about their treatment options. No illnesses or adverse effects have been reported in connection with this 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
- Hazard
- impurities
- 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#: GPC250158A
- Exp Date: 06-22-2027
UPCs (6)
- 0370010029019
- 0370010030015
- 0370010032019
- 0370010034013
- 0370010031012
- 0370010033016
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
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- ModerateFDA Recalls Amphetamine Extended-Release Capsules for Failed Specifications
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- ModerateFDA Recalls Dextroamphetamine Extended-Release Capsules for Failed Purity Specifications
FDA (Drugs) · 2025-10-01
- ModerateExtended-Release Amphetamine Capsules Recalled for Failed Purity Specifications
FDA (Drugs) · 2025-10-01
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