Granules Pharmaceuticals Inc. recalled 3,384 bottles of amphetamine capsules on August 28, 2025. The recall follows a failure to meet impurities and degradation specifications. Consumers should stop using this product immediately and consult healthcare providers.
Failed Impurities/Degradation Specifications:
Consumers and healthcare providers should stop using this product immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: E-Mail
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The recall involves Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, 100 capsules per bottle. The affected lot number is GPC250158A, with an expiration date of June 22, 2027.
The product failed to meet established impurities and degradation specifications. This could pose health risks to users, particularly affecting efficacy and safety.
No specific incidents or injuries were reported in connection with this recall. However, the nature of the degradation could potentially impact patients using the medication.
Consumers and healthcare providers should stop using the affected capsules immediately. Contact Granules Pharmaceuticals Inc. or your healthcare provider for guidance on next steps.
For more information, consumers can email Granules Pharmaceuticals Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0669-2025.
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