Extended-Release Amphetamine Capsules Recalled for Failed Purity Specifications
Granules Pharmaceuticals Inc. is recalling 9,917 bottles of Extended-Release Amphetamine Capsules (15 mg) distributed nationwide due to failed impurities and degradation specifications in lot GPC250178A.
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 hazard is a quality-control failure (failed impurities and degradation specifications) rather than a named pathogen or allergen. Class III recalls are typically scored 1 or 2; this rates as 2 because it represents a substantive specification failure, not merely a labeling or cosmetic issue.
Plain-English summary
Granules Pharmaceuticals Inc. is recalling 9,917 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 15 mg (NDC 70010-031-01), distributed nationwide in the United States. The recall was initiated due to failed impurities and degradation specifications.
The affected product is lot number GPC250178A, which has an expiration date of June 22, 2027. The recall applies to 100-capsule bottles of this lot.
Consumers and healthcare providers with questions about this recall should contact Granules Pharmaceuticals Inc. or the FDA.
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.
- 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#: GPC250178A
- Exp Date: 06-22-2027
UPCs (6)
- 0370010029019
- 0370010030015
- 0370010032019
- 0370010034013
- 0370010031012
- 0370010033016
Distribution
Distributed nationwide across the United States.
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